Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
dal-GenE
A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial
1 other identifier
interventional
6,147
31 countries
551
Brief Summary
A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2016
Longer than P75 for phase_3
551 active sites
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
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedResults Posted
Study results publicly available
October 12, 2022
CompletedOctober 12, 2022
September 1, 2022
5.5 years
August 13, 2015
September 1, 2022
October 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke
All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the CEC.
From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)
Secondary Outcomes (2)
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure
From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Study Arms (2)
Dalcetrapib
ACTIVE COMPARATORParticipants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
Placebo
PLACEBO COMPARATORParticipants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
- AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS)
- Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
- Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C \<100 mg/dl (\<2.6 mmol/L).
You may not qualify if:
- Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
- Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using at least one method of contraception\*
- New York Heart Association (NYHA) Class III or IV heart failure
- Last known hemoglobin \<10 g/dL
- Index ACS event presumed due to uncontrolled hypertension
- (\*) Varies by region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DalCor Pharmaceuticalslead
- The Montreal Health Innovations Coordinating Center (MHICC)collaborator
- Medpace, Inc.collaborator
- Roche Molecular Systems, Inccollaborator
Study Sites (557)
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Alexander City, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Cottonwood, Arizona, United States
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Glendale, Arizona, United States
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Jonesboro, Arkansas, United States
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Huntington Beach, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Danbury, Connecticut, United States
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Hartford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Homestead, Florida, United States
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Hudson, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Miramar, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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Safety Harbor, Florida, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Covington, Georgia, United States
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Decatur, Georgia, United States
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Macon, Georgia, United States
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Evanston, Illinois, United States
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Jerseyville, Illinois, United States
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Fort Wayne, Indiana, United States
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Newburgh, Indiana, United States
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West Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Owensboro, Kentucky, United States
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Alexandria, Louisiana, United States
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Covington, Louisiana, United States
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Bangor, Maine, United States
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Biddeford, Maine, United States
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Lewiston, Maine, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Salisbury, Maryland, United States
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Hyannis, Massachusetts, United States
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Alpena, Michigan, United States
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Bay City, Michigan, United States
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Lansing, Michigan, United States
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Midland, Michigan, United States
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Mount Clemens, Michigan, United States
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Muskegon, Michigan, United States
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Saginaw, Michigan, United States
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Saint Joseph, Michigan, United States
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Ypsilanti, Michigan, United States
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Coon Rapids, Minnesota, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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St Louis, Missouri, United States
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Washington, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Bridgewater, New Jersey, United States
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Linden, New Jersey, United States
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Somerset, New Jersey, United States
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Summit, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Asheville, North Carolina, United States
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Greensboro, North Carolina, United States
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Pinehurst, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Minot, North Dakota, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Springfield, Ohio, United States
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Toledo, Ohio, United States
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Zanesville, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Butler, Pennsylvania, United States
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Chambersburg, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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York, Pennsylvania, United States
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Providence, Rhode Island, United States
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Spartanburg, South Carolina, United States
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Rapid City, South Dakota, United States
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Greeneville, Tennessee, United States
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Jackson, Tennessee, United States
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Layton, Utah, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Winchester, Virginia, United States
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Seattle, Washington, United States
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La Crosse, Wisconsin, United States
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Buenos Aires, Argentina
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Corrientes, Argentina
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Quilmes, Argentina
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San Juan, Argentina
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Venado Tuerto, Argentina
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Villa Allende, Argentina
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Bruce, New South Wales, Australia
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Gosford, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Saint Leonards, New South Wales, Australia
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Cairns, Queensland, Australia
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Chermside, Queensland, Australia
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Douglas, Queensland, Australia
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Herston, Queensland, Australia
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Milton, Queensland, Australia
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Redcliffe, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Bedford Park, South Australia, Australia
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Elizabeth Vale, South Australia, Australia
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Woodville South, South Australia, Australia
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Hobart, Tasmania, Australia
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Epping, Victoria, Australia
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Geelong, Victoria, Australia
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Melbourne, Victoria, Australia
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Joondalup, Western Australia, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Braunau am Inn, Austria
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Krems, Austria
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Linz, Austria
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Maaseik, Belgium
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Mechelen, Belgium
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Sint-Niklaas, Belgium
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Belo Horizonte, Brazil
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Campinas, Brazil
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Fortaleza, Brazil
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Marília, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Uberlândia, Brazil
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Vitória, Brazil
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Blagoevgrad, Bulgaria
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Dimitrovgrad, Bulgaria
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Haskovo, Bulgaria
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Pazardzhik, Bulgaria
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Pernik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sandanski, Bulgaria
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Sofia, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Bridgewater, Nova Scotia, Canada
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Burlington, Ontario, Canada
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Cambridge, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Granby, Quebec, Canada
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Laval, Quebec, Canada
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Lévis, Quebec, Canada
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Longueuil, Quebec, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, Canada
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Saint George, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saint-Jean-sur-Richelieu, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Terrebonne, Quebec, Canada
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Thetford-Mines, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Québec, Canada
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Santiago, Chile
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Temuco, Chile
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Viña del Mar, Chile
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Bílina, Czechia
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Brno, Czechia
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Hradec Králové, Czechia
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Jihlava, Czechia
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Kladno, Czechia
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Kroměříž, Czechia
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Liberec, Czechia
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Náchod, Czechia
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Pilsen, Czechia
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Písek, Czechia
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Prague, Czechia
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Slaný, Czechia
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Trutnov, Czechia
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Zlín, Czechia
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Aalborg, Denmark
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Copenhagen, Denmark
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Frederiksberg, Denmark
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Glostrup Municipality, Denmark
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Hellerup, Denmark
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Herning, Denmark
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Hillerød, Denmark
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Næstved, Denmark
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Silkeborg, Denmark
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Jyväskylä, Finland
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Oulu, Finland
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Pori, Finland
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Turku, Finland
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Besançon, France
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Bron, France
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Clermont-Ferrand, France
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Corbeil-Essonnes, France
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Dijon, France
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Limoges, France
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Lyon, France
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Montpellier, France
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Paris, France
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Pessac, France
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Poitiers, France
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Toulouse, France
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Tourcoing, France
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Valenciennes, France
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Aachen, Germany
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Berlin, Germany
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Bochum, Germany
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Bremen, Germany
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Chemnitz, Germany
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Coburg, Germany
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Dresden, Germany
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Erfurt, Germany
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Fürth, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Mainz, Germany
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Mönchengladbach, Germany
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Munich, Germany
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Baja, Hungary
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Balatonfüred, Hungary
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Budapest, Hungary
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Eger, Hungary
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Gyula, Hungary
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Hatvan, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Székesfehérvár, Hungary
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Szombathely, Hungary
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Zalaegerszeg, Hungary
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Afula, Israel
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Ashkelon, Israel
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Beersheba, Israel
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Bnei Brak, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Nahariya, Israel
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Nazareth, Israel
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Petah Tikva, Israel
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Poria Illit, Israel
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Rehovot, Israel
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Safed, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Ẕerifin, Israel
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Ancona, Italy
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Ascoli Piceno, Italy
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Cagliari, Italy
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Casarano, Italy
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Cortona, Italy
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Empoli, Italy
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Florence, Italy
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Foggia, Italy
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Giugliano in Campania, Italy
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Gubbio, Italy
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Milan, Italy
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Napoli, Italy
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Novara, Italy
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Roma, Italy
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Rozzano, Italy
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Sanremo, Italy
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Saronno, Italy
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Scorrano, Italy
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Seriate, Italy
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Torino, Italy
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Treviglio, Italy
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's-Hertogenbosch, Netherlands
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Capelle aan den IJssel, Netherlands
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Deventer, Netherlands
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Doetinchem, Netherlands
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Ede, Netherlands
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Goes, Netherlands
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Gouda, Netherlands
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Hoogeveen, Netherlands
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Hoorn, Netherlands
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Leeuwarden, Netherlands
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Leiden, Netherlands
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Rotterdam, Netherlands
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Schiedam, Netherlands
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Sneek, Netherlands
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The Hague, Netherlands
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Tiel, Netherlands
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Tilburg, Netherlands
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Uden, Netherlands
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Veldhoven, Netherlands
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Venlo, Netherlands
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Zaandam, Netherlands
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Zutphen, Netherlands
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Hamilton, New Zealand
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Hastings, New Zealand
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Lower Hutt, New Zealand
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Nelson, New Zealand
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New Plymouth, New Zealand
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Rotorua, New Zealand
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Takapuna, New Zealand
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Wellington, New Zealand
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Bydgoszcz, Poland
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Gdynia, Poland
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Krakow, Poland
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Sopot, Poland
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Faro, Portugal
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Leiria, Portugal
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Senhora da Hora, Portugal
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Setúbal, Portugal
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Bayamón, Puerto Rico
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Falun, Sweden
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Research Site
Worthing, United Kingdom
Related Publications (3)
Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374.
PMID: 35856777DERIVEDBlack DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093.
PMID: 34173811DERIVEDTardif JC, Dube MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.
PMID: 32087417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The main limitation of this study is the occurrence of the COVID-19 pandemic during study conduct.
Results Point of Contact
- Title
- Dr. Don Black, Chief Medical Officer
- Organization
- DalCor Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Donald M Black, MD
DalCor Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
August 13, 2015
First Posted
August 18, 2015
Study Start
April 1, 2016
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
October 12, 2022
Results First Posted
October 12, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share