NCT01687998

Brief Summary

The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
12,092

participants targeted

Target at P75+ for phase_3 cardiovascular-diseases

Timeline
Completed

Started Oct 2012

Geographic Reach
35 countries

438 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 16, 2018

Completed
Last Updated

October 8, 2019

Status Verified

September 1, 2019

Enrollment Period

3.4 years

First QC Date

September 12, 2012

Results QC Date

February 18, 2018

Last Update Submit

September 25, 2019

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)

    For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.

    Baseline to Study Completion (Up to 4 years)

Secondary Outcomes (5)

  • Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels

    Baseline, 3 Months

  • Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA

    Baseline through End of Study (Up to 4 years)

  • Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization

    Baseline through End of Study (Up to 4 years)

  • Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA

    Baseline through End of Study (Up to 4 years)

  • Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke

    Baseline through End of Study (Up to 4 years)

Study Arms (2)

Evacetrapib

EXPERIMENTAL

Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).

Drug: Evacetrapib

Placebo

PLACEBO COMPARATOR

Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.

Drug: Placebo

Interventions

EvacetrapibDRUG

Administered Orally

Also known as: LY2484595
Evacetrapib
PlaceboDRUG

Administered Orally

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of: 1)History of acute coronary syndrome (ACS) (that is, ≥30 days through 365 days after discharge for ACS) 2)cerebrovascular atherosclerotic disease 3)peripheral arterial disease 4)diabetes mellitus with documented coronary artery disease and are clinically stable (as judged by the responsible physician).
  • Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin must have documented statin intolerance, or contraindication to statin
  • Have a screening high-density lipoprotein cholesterol (HDL-C) ≤80 milligram per deciliter (mg/dL) (≤2.1 millimole per liter \[mmol/L\])
  • Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)
  • Meet 1 of the following criteria:
  • screening low-density lipoprotein cholesterol (LDL-C) no more than 10 mg/dL (0.3 mmol/L) above the target chosen by the investigator (either LDL-C \<100 mg/dL \[\<2.6 mmol/L\] or LDL-C \<70 mg/dL \[\<1.8 mmol/L\]), OR
  • if LDL-C is greater than target, the participant must be on maximum tolerated statin dose (for at least 30 days), have documented statin intolerance, or contraindication to statin

You may not qualify if:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
  • Female participants who are known to be pregnant or breastfeeding
  • Women of child-bearing potential only, who test positive for pregnancy between screening and randomization, or who do not agree to use a reliable method of birth control during the study
  • History of transient ischemic attack (TIA) or ischemic stroke \<30 days and ACS \<30 days
  • Any reading of systolic blood pressure ≥180 millimeter of mercury (mm Hg) or diastolic blood pressure ≥110 mm Hg at screening or randomization
  • History of hemorrhagic stroke or intracranial hemorrhage
  • New York Heart Association class III or IV congestive heart failure
  • Serum creatinine \>2.2 mg/dL (\>194.5 micromole per liter \[μmol/L\]) at screening
  • Clinically active liver disease. Participants are not excluded due to Gilbert's Syndrome or a history of cholelithiasis/cholecystectomy
  • History of malignancy within the preceding 3 years prior to screening
  • Known malabsorption syndrome with the exception of lactose intolerance
  • Participants with a known history of primary or secondary hyperaldosteronism
  • Participants with a history of intolerance/hypersensitivity to cholesterol ester transfer protein (CETP) inhibitors
  • Any clinically significant medical condition that according to the investigator could interfere with participation in the study
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (444)

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Birmingham, Alabama, 35233, United States

Location

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Huntsville, Alabama, 35801, United States

Location

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Mobile, Alabama, 36608, United States

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Cottonwood, Arizona, 86326, United States

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Glendale, Arizona, 85306, United States

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Tucson, Arizona, 85724, United States

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Fort Smith, Arkansas, 72901, United States

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Little Rock, Arkansas, 72205, United States

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Escondido, California, 92029, United States

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Fresno, California, 93710, United States

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Lomita, California, 90717, United States

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Long Beach, California, 90822, United States

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Mission Viejo, California, 92691, United States

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Santa Rosa, California, 95405, United States

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Stockton, California, 95204, United States

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Thousand Oaks, California, 91360, United States

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Torrance, California, 90509, United States

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Colorado Springs, Colorado, 80909, United States

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Golden, Colorado, 80401, United States

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Bridgeport, Connecticut, 06606, United States

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Waterbury, Connecticut, 06708, United States

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Aventura, Florida, 33180, United States

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Boynton Beach, Florida, 33472, United States

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Brandon, Florida, 33511, United States

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Clearwater, Florida, 33756, United States

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Fleming Island, Florida, 32003, United States

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Gainesville, Florida, 32605, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32258, United States

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Jacksonville Beach, Florida, FL, United States

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Jupiter, Florida, 33458, United States

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Lakeland, Florida, 33805, United States

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Largo, Florida, 33777, United States

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Margate, Florida, 33063, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33135, United States

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Miami Beach, Florida, 33140, United States

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Naples, Florida, 34102, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32803, United States

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Panama City, Florida, 32401, United States

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Pembroke Pines, Florida, 33026, United States

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Pensacola, Florida, 32501, United States

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Ponte Vedra, Florida, 32081, United States

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Port Charlotte, Florida, 33952, United States

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Safety Harbor, Florida, 34695, United States

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Tallahassee, Florida, 32308, United States

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Wellington, Florida, 33449, United States

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Covington, Georgia, 30014, United States

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Cumming, Georgia, 30041, United States

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Tucker, Georgia, 30084, United States

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Arlington Heights, Illinois, 60005, United States

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Aurora, Illinois, 60504, United States

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Bannockburn, Illinois, 60015, United States

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Jerseyville, Illinois, 62052, United States

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Rock Island, Illinois, 61201, United States

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Anderson, Indiana, 46011, United States

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Brownsburg, Indiana, 46112, United States

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Elkhart, Indiana, 46514, United States

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Fort Wayne, Indiana, 46845, United States

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Hammond, Indiana, 46320, United States

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Indianapolis, Indiana, 46290, United States

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Waterloo, Iowa, 50702, United States

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Hutchinson, Kansas, 67502, United States

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Overland Park, Kansas, 66209, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40207, United States

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Baton Rouge, Louisiana, 70808, United States

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Covington, Louisiana, 70433, United States

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Lake Charles, Louisiana, 70601, United States

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Auburn, Maine, 04210, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21237, United States

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Columbia, Maryland, 21044, United States

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Lutherville, Maryland, 21093, United States

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Salisbury, Maryland, 21804, United States

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Haverhill, Massachusetts, 01830, United States

Location

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Hyannis, Massachusetts, 02601, United States

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Natick, Massachusetts, 01760, United States

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Springfield, Massachusetts, 01199, United States

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Cadillac, Michigan, 49601, United States

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Lansing, Michigan, 48910, United States

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Marquette, Michigan, 49855, United States

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Midland, Michigan, 48670, United States

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Novi, Michigan, 48374, United States

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Petoskey, Michigan, 49770, United States

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Saginaw, Michigan, 48601, United States

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Saint Paul, Minnesota, 55101 2595, United States

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Columbia, Missouri, 65201, United States

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Springfield, Missouri, 65804, United States

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St Louis, Missouri, 63128, United States

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Omaha, Nebraska, 68114, United States

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Bridgewater, New Jersey, 08807, United States

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Elizabeth, New Jersey, 07202, United States

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Elmer, New Jersey, 08318, United States

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Ridgewood, New Jersey, 07450, United States

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Somerset, New Jersey, 08873, United States

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Teaneck, New Jersey, 07666, United States

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Albany, New York, 12211, United States

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Kingston, New York, 12401, United States

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Poughkeepsie, New York, 12601, United States

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Saratoga Springs, New York, 12866, United States

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Southampton, New York, 11968, United States

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Troy, New York, 12180, United States

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Westfield, New York, 14787, United States

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Williamsville, New York, 14221, United States

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Cary, North Carolina, 27518, United States

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Elizabeth City, North Carolina, 27909, United States

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Greensboro, North Carolina, 27408, United States

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Hickory, North Carolina, 28602, United States

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Lenoir, North Carolina, 28645, United States

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Wilmington, North Carolina, 28401, United States

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Beachwood, Ohio, 44122, United States

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Canton, Ohio, 44708, United States

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Cincinnati, Ohio, 45220, United States

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Sandusky, Ohio, 44870, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73135, United States

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Portland, Oregon, 97225, United States

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Beaver, Pennsylvania, 15009, United States

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Bethlehem, Pennsylvania, 18018, United States

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Danville, Pennsylvania, 17822, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19152, United States

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Port Matilda, Pennsylvania, 16870, United States

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Red Lion, Pennsylvania, 17356, United States

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Wilkes-Barre, Pennsylvania, 18711, United States

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Cumberland, Rhode Island, 02864, United States

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Columbia, South Carolina, 29204, United States

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Greenville, South Carolina, 29607, United States

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Greer, South Carolina, 29650, United States

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Rapid City, South Dakota, 57701, United States

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Greeneville, Tennessee, 37745, United States

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Knoxville, Tennessee, 37917, United States

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Nashville, Tennessee, 37203, United States

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Tullahoma, Tennessee, 37388, United States

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Corpus Christi, Texas, 78404, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77074, United States

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Kerrville, Texas, 78028, United States

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Kingwood, Texas, 77339, United States

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San Antonio, Texas, 78217, United States

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Tomball, Texas, 77375, United States

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Bountiful, Utah, 84010, United States

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Murray, Utah, 84123, United States

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Salt Lake City, Utah, 84124, United States

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Charlottesville, Virginia, 22908, United States

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Danville, Virginia, 24541, United States

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Falls Church, Virginia, 22042, United States

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Harrisonburg, Virginia, 22801, United States

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Lynchburg, Virginia, 24501, United States

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Roanoke, Virginia, 24014, United States

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Madison, Wisconsin, 53792, United States

Location

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Milwaukee, Wisconsin, 53295, United States

Location

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Oregon, Wisconsin, 53575, United States

Location

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Belgrano, C1428DCO, Argentina

Location

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Buenos Aires, CBA 1425, Argentina

Location

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Coronel Suárez, B7540GHD, Argentina

Location

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Córdoba, 5006, Argentina

Location

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San Luis, D5702JRS, Argentina

Location

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San Miguel de Tucumán, T4000NIL, Argentina

Location

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Camperdown, New South Wales, 2050, Australia

Location

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Wollongong, New South Wales, 2522, Australia

Location

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Herston, Queensland, 4029, Australia

Location

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Milton, Queensland, 4064, Australia

Location

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Southport, Queensland, 4215, Australia

Location

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Woodville, South Australia, 5011, Australia

Location

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Launceston, Tasmania, 7250, Australia

Location

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Box Hill, Victoria, 3128, Australia

Location

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Geelong, Victoria, 3220, Australia

Location

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Heidelberg, Victoria, 3084, Australia

Location

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Melbourne, Victoria, 3162, Australia

Location

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Windsor, Victoria, 3183, Australia

Location

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Feldkirch, 6807, Austria

Location

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Graz, 8036, Austria

Location

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Innsbruck, 6020, Austria

Location

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Vienna, 1140, Austria

Location

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Antwerp, 2060, Belgium

Location

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Brussels, 01200, Belgium

Location

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Huy, 4500, Belgium

Location

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Merksem, 2170, Belgium

Location

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Tienen, 3300, Belgium

Location

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Fortaleza, 60430-370, Brazil

Location

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Rio de Janeiro, 22271-100, Brazil

Location

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São Paulo, 05403-000, Brazil

Location

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Gabrovo, 5300, Bulgaria

Location

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Pazardzhik, 4400, Bulgaria

Location

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Pleven, 5800, Bulgaria

Location

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Plovdiv, 4000, Bulgaria

Location

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Smolyan, 4700, Bulgaria

Location

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Sofia, 1527, Bulgaria

Location

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Kelowna, British Columbia, V1Y 1V6, Canada

Location

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Mount Pearl, Newfoundland and Labrador, A1N 2C3, Canada

Location

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Cambridge, Ontario, N1R 6V6, Canada

Location

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Greater Sudbury, Ontario, P3E 2N8, Canada

Location

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Hamilton, Ontario, L8L 2X2, Canada

Location

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Mississauga, Ontario, L5B 2P7, Canada

Location

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Oshawa, Ontario, L1J 2J9, Canada

Location

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Sarnia, Ontario, N7T 6K9, Canada

Location

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Thunder Bay, Ontario, P7B 7C7, Canada

Location

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Toronto, Ontario, M5C 2T2, Canada

Location

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Brossard, Quebec, J4X 1S4, Canada

Location

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Chicoutimi, Quebec, G7H 5H6, Canada

Location

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Gatineau, Quebec, J8Y6S9, Canada

Location

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Greenfield Park, Quebec, J4V 2G8, Canada

Location

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Joilette, Quebec, J6E 6J2, Canada

Location

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Longueuil, Quebec, J4M 2X1, Canada

Location

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Montreal, Quebec, H1T 1C8, Canada

Location

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Saint-Georges, Quebec, G5Y 4T8, Canada

Location

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

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Saint-Lambert, Quebec, J4P 2H4, Canada

Location

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Sainte-Foy, Quebec, G1V 4G5, Canada

Location

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Beijing, 100034, China

Location

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Changsha, 410005, China

Location

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Guangzhou, 510515, China

Location

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Harbin, 150001, China

Location

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Shanghai, 200032, China

Location

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Shenyang, 110004, China

Location

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Český Krumlov, 381 01, Czechia

Location

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Hodonín, 69501, Czechia

Location

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Mariánské Lázně, 35301, Czechia

Location

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Pardubice, 53002, Czechia

Location

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Písek, 39701, Czechia

Location

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Prague, 13000, Czechia

Location

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Příbram, 26101, Czechia

Location

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Teplice, 41501, Czechia

Location

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Aalborg, 9000, Denmark

Location

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Ballerup Municipality, 2750, Denmark

Location

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Copenhagen, 2300, Denmark

Location

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Copenhagen, 2400, Denmark

Location

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Vejle, 7100, Denmark

Location

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Tallinn, 10128, Estonia

Location

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Viljandi, 71024, Estonia

Location

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Bordeaux, 33000, France

Location

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Dijon, 21000, France

Location

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Le Coudray, 28630, France

Location

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Paris, 75651, France

Location

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Pessac, 33600, France

Location

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Strasbourg, 67091, France

Location

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Toulouse, 31059, France

Location

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Altenburg, 04600, Germany

Location

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Bad Krozingen, 79189, Germany

Location

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Berlin, 13347, Germany

Location

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Bielefeld, 33604, Germany

Location

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Dortmund, 44137, Germany

Location

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Dresden, 01067, Germany

Location

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Frankfurt, 65929, Germany

Location

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Heidelberg, 69120, Germany

Location

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Kassel, 34121, Germany

Location

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Mainz, 55131, Germany

Location

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Mönchengladbach, 41063, Germany

Location

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Stuttgart, 70376, Germany

Location

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Tübingen, D-72076, Germany

Location

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Warendorf, 48231, Germany

Location

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Wiesbaden, 65199, Germany

Location

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Central, Hong Kong

Location

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Hong Kong, Hong Kong

Location

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Shatin, Hong Kong

Location

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Békéscsaba, 5600, Hungary

Location

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Budapest, 1096, Hungary

Location

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Debrecen, 4025, Hungary

Location

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Esztergom, 2500, Hungary

Location

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Hódmezővásárhely, 6800, Hungary

Location

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Kalocsa, H-6300, Hungary

Location

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Komárom, 2921, Hungary

Location

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Orosháza, 5901, Hungary

Location

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Szekszárd, 7100, Hungary

Location

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Zalaegerszeg, 8900, Hungary

Location

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Haifa, 31096, Israel

Location

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Jerusalem, 91004, Israel

Location

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Nazareth, 16100, Israel

Location

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Rehovot, 76100, Israel

Location

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Safed, 13110, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Tel Litwinsky, 52621, Israel

Location

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Bologna, 40138, Italy

Location

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Castelfranco Veneto, 31033, Italy

Location

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Chieti Scalo, 66013, Italy

Location

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Milan, 20138, Italy

Location

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Napoli, 80131, Italy

Location

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Novara, 28100, Italy

Location

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Parma, 43100, Italy

Location

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Piacenza, 29100, Italy

Location

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San Daniele del Friuli, 33038, Italy

Location

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Sessa Aurunca, 81037, Italy

Location

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Aichi, 470-1192, Japan

Location

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Chiba, 270-2251, Japan

Location

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Ehime, 798-8510, Japan

Location

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Fukuoka, 830-8543, Japan

Location

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Gunma, 377-0061, Japan

Location

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Hyōgo, 665-0022, Japan

Location

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Ibaraki, 311-3193, Japan

Location

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Ishikawa, 920-8641, Japan

Location

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Kanagawa, 232-0024, Japan

Location

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Kumamoto, 860-8556, Japan

Location

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Kyoto, 661-0042, Japan

Location

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Okinawa, 901-0493, Japan

Location

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Osaka, 581-0011, Japan

Location

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Saitama, 351-0102, Japan

Location

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Shizuoka, 411-8611, Japan

Location

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Tokushima, 770-8539, Japan

Location

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Tokyo, 152-8902, Japan

Location

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Yamaguchi, 740-8510, Japan

Location

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Kaunas, LT-50009, Lithuania

Location

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Klaipėda, LT-92288, Lithuania

Location

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Vilnius, LT-10323, Lithuania

Location

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Aguascalientes, 20230, Mexico

Location

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Chihuahua City, 31238, Mexico

Location

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Cul Sinaloa, 80020, Mexico

Location

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Guadalajara, 44130, Mexico

Location

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Huixquilucan, 52763, Mexico

Location

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Mexico City, 11850, Mexico

Location

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Querétaro, 76000, Mexico

Location

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San Luis Potosí City, 78216, Mexico

Location

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Tampico, 89000, Mexico

Location

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Tijuana, 22500, Mexico

Location

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's-Hertogenbosch, 5223 GV, Netherlands

Location

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Amersfoort, 3818 ES, Netherlands

Location

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Amsterdam, 1105 AZ, Netherlands

Location

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Beverwijk, 1942 LE, Netherlands

Location

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Delft, 2625 AD, Netherlands

Location

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Den Helder, 1782 GZ, Netherlands

Location

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Deventer, 7416 SE, Netherlands

Location

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Drachten, 9202 NN, Netherlands

Location

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Heerlen, 6401CX, Netherlands

Location

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Hilversum, 1213 XZ, Netherlands

Location

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Hoogeveen, 7909AA, Netherlands

Location

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Hoorn, 1625 HV, Netherlands

Location

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Leiden, 2333, Netherlands

Location

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Tilburg, 5042 AD, Netherlands

Location

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Venlo, 5912 BL, Netherlands

Location

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Waalwijk, 5141 BM, Netherlands

Location

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Zaandam, 1502 DV, Netherlands

Location

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Zwijndrecht, 3331 LZ, Netherlands

Location

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Addington, 8011, New Zealand

Location

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Grafton, 1023, New Zealand

Location

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Hamilton West, 3204, New Zealand

Location

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Newtown, 6021, New Zealand

Location

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Tauranga, 3140, New Zealand

Location

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Westlake, 0620, New Zealand

Location

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Bydgoszcz, 85-863, Poland

Location

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Gdansk, 80-126, Poland

Location

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Katowice, 40-752, Poland

Location

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Krakow, 30-510, Poland

Location

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Kutno, 99-300, Poland

Location

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Lodz, 94-255, Poland

Location

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Oława, 55-200, Poland

Location

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Puławy, 24-100, Poland

Location

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Skierniewice, 96-100, Poland

Location

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Sobótka, 55050, Poland

Location

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Warsaw, 04-730, Poland

Location

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Wroclaw, 51-112, Poland

Location

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Ponce, 00717-1322, Puerto Rico

Location

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San Juan, 00909, Puerto Rico

Location

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Trujillo Alto, 00976, Puerto Rico

Location

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Brăila, 810249, Romania

Location

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Bucharest, 022328, Romania

Location

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Buzău, 120203, Romania

Location

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Focşani, 620034, Romania

Location

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Oradea, 410169, Romania

Location

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Arkhangelsk, 163045, Russia

Location

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Kemerovo, 650002, Russia

Location

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Moscow, 111020, Russia

Location

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Saint Petersburg, 196105, Russia

Location

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Smolensk, 214019, Russia

Location

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Tomsk, 196105, Russia

Location

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Yaroslavl, 150002, Russia

Location

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Bardejov, 08501, Slovakia

Location

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Bratislava, 85101, Slovakia

Location

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Kráľovský Chlmec, 07701, Slovakia

Location

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Nitra, 949 01, Slovakia

Location

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Prešov, 080 01, Slovakia

Location

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Žilina, 010 01, Slovakia

Location

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Alberton, 1449, South Africa

Location

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Bellville, 7530, South Africa

Location

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Bloemfontein, 9300, South Africa

Location

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Goodwood, 7460, South Africa

Location

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Johannesburg, 1460, South Africa

Location

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Kuilsriver, 7580, South Africa

Location

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Newlands West, 4035, South Africa

Location

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Parktown West, 2193, South Africa

Location

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Worcester, 6850, South Africa

Location

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Anyang, 431-070, South Korea

Location

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Busan, 614-735, South Korea

Location

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Daejeon, 301-721, South Korea

Location

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Gangwon-Do, 200-722, South Korea

Location

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Goyang, 410-773, South Korea

Location

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Gwangju, 510-757, South Korea

Location

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Jungbuk, 361-711, South Korea

Location

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Seoul, 137-701, South Korea

Location

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Ciudad Real, 13005, Spain

Location

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Córdoba, 14004, Spain

Location

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L'Hospitalet de Llobregat, 08907, Spain

Location

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Madrid, 28040, Spain

Location

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Málaga, 29010, Spain

Location

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Palma de Mallorca, 07198, Spain

Location

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Pamplona, 31008, Spain

Location

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Lund, 22221, Sweden

Location

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Malmo, 20502, Sweden

Location

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Östersund, 83183, Sweden

Location

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Stockholm, 11157, Sweden

Location

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Lugano, CH-6900, Switzerland

Location

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Zurich, CH-8091, Switzerland

Location

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Kaohsiung City, 807, Taiwan

Location

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Kaohsiung City, 83301, Taiwan

Location

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Kuei Shan Hsiang, 33305, Taiwan

Location

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Taichung, 40201, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Taipei, 111, Taiwan

Location

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Ankara, 06520, Turkey (Türkiye)

Location

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Konya, 42250, Turkey (Türkiye)

Location

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Kyiv, 2091, Ukraine

Location

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Lutsk, 43024, Ukraine

Location

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Poltava, 36038, Ukraine

Location

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Saint Stephen, Cornwall, PL26 7RL, United Kingdom

Location

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Welwyn Garden City, Hertfordshire, AL7 4HQ, United Kingdom

Location

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Barnet, Herts, EN5 3DJ, United Kingdom

Location

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Stevenage, Herts, SG4 7NH, United Kingdom

Location

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Tooting, London, SW17 ORE, United Kingdom

Location

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Wellingborough, Northants, NN8 4RW, United Kingdom

Location

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Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

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Bath, BA2 4BY, United Kingdom

Location

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Frome, BA11 1EZ, United Kingdom

Location

Related Publications (4)

  • Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Oct 1;5(10):1136-1143. doi: 10.1001/jamacardio.2020.2413.

    PMID: 32639518DERIVED

  • Menon V, Kumar A, Patel DR, John JS, Wolski KE, McErlean E, Riesmeyer JS, Weerakkody G, Ruotolo G, Cremer PC, Nicholls SJ, Lincoff AM, Nissen SE. Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy. J Am Heart Assoc. 2020 Jan 7;9(1):e014328. doi: 10.1161/JAHA.119.014328. Epub 2019 Dec 19.

    PMID: 31852422DERIVED

  • Kumar A, Patel DR, Brennan DM, Wolski KE, Lincoff AM, Ruotolo G, McErlean E, Weerakkody G, Riesmeyer JS, Nicholls SJ, Nissen SE, Menon V. Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e013790. doi: 10.1161/JAHA.119.013790. Epub 2019 Nov 22.

    PMID: 31752637DERIVED

  • Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE; ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.

    PMID: 28514624DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

evacetrapib

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 19, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2016

Study Completion

July 1, 2016

Last Updated

October 8, 2019

Results First Posted

May 16, 2018

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

AU(12)LI(3)RU(7)SL(6)BE(5)US(176)ES(7)TU(2)DE(15)GB(9)NZ(6)HU(10)ME(10)JP(18)RO(5)BR(3)KR(8)UA(3)BU(6)HK(3)IL(7)DK(5)NL(18)ZA(9)CH(2)CN(6)AR(6)IT(10)PL(12)FR(7)CA(21)PR(3)SE(4)TW(6)CZ(8)