Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
dal-GenE-2
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)
1 other identifier
interventional
2,000
3 countries
223
Brief Summary
This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 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. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from 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 (up to12 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 Oct 2023
Typical duration for phase_3
223 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
June 15, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedStudy Start
First participant enrolled
October 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
January 7, 2026
January 1, 2026
3.8 years
June 15, 2023
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)
Time to patients experiencing major cardiovascular events
Average of 30 months from randomization
Secondary Outcomes (3)
The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Average of 30 months from randomization
Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Average of 30 months from randomization
Fatal and non-fatal MI
Average of 30 months from randomization
Study Arms (2)
Dalcetrapib
EXPERIMENTALDalcetrapib 600 mg (two 300 mg tablets) orally once daily
Placebo
PLACEBO COMPARATORMatching dalcetrapib placebo tablets (2 tablets) orally once per day
Interventions
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
Eligibility Criteria
You may qualify if:
- Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.
- Both male and female subjects age 45 years and over at screening visit (V1)
- AA genotype at variant gene as determined by Genotype Assay Test, 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, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
- Randomization within 3 months of the index ACS event
You may not qualify if:
- Females who are pregnant (negative urine 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 highly effective method of contraception.
- New York Heart Association (NYHA) Class III or IV heart failure
- Index ACS event presumed due to uncontrolled hypertension
- Systolic blood pressure (BP) \>180 mmHg and/or diastolic blood pressure \>110 mmHg at the time of randomization despite anti-hypertensive therapy
- Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level \>3 x ULN within 6 months prior to randomization (excluding index event)
- History of persistent and unexplained creatine phosphokinase (CPK) levels \> 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)
- Last known eGFR \< 30 mL/min/1.73m2 as assessed within 6 months prior to randomization
- History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.
- Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study
- Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
- Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (223)
Research Site
Alexander City, Alabama, 35010, United States
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Birmingham, Alabama, 35211, United States
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Fairhope, Alabama, 36532, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Scottsdale, Arizona, 85258, United States
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Tucson, Arizona, 85724, United States
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Jonesboro, Arkansas, 72405, United States
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North Little Rock, Arkansas, 72117, United States
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Garden Grove, California, 92844, United States
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Huntington Beach, California, 92648, United States
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La Jolla, California, 92037, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90025, United States
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Newport Beach, California, 92648, United States
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Newport Beach, California, 92658, United States
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San Francisco, California, 94143, United States
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Santa Barbara, California, 93105, United States
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Stanford, California, 94305, United States
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Torrance, California, 90502, United States
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West Hills, California, 91307, United States
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Aurora, Colorado, 80011, United States
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Golden, Colorado, 80401, United States
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Hartford, Connecticut, 06102, United States
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New Haven, Connecticut, 06519, United States
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Newark, Delaware, 19718, United States
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Washington D.C., District of Columbia, 20010, United States
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Washington D.C., District of Columbia, 20060, United States
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Boca Raton, Florida, 33434, United States
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Boca Raton, Florida, 33486, United States
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Clearwater, Florida, 33756, United States
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Doral, Florida, 33166, United States
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Fort Lauderdale, Florida, 33316, United States
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Fort Myers, Florida, 33908, United States
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Gainesville, Florida, 32608, United States
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Hialeah, Florida, 33013, United States
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Homestead, Florida, 33030, United States
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Jacksonville, Florida, 32209, United States
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Kissimmee, Florida, 34741, United States
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Largo, Florida, 33777, United States
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Miami, Florida, 33032, United States
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Miami, Florida, 33033, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33145, United States
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Miami, Florida, 33175, United States
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Miami Lakes, Florida, 33014, United States
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Miami Lakes, Florida, 33016, United States
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Ocala, Florida, 34471, United States
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Pembroke Pines, Florida, 33024, United States
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Pensacola, Florida, 32502, 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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Sarasota, Florida, 34239, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33606, United States
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Tampa, Florida, 33607, United States
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Winter Haven, Florida, 33881, United States
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Acworth, Georgia, 30101, United States
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Atlanta, Georgia, 30310, United States
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Atlanta, Georgia, 30322, United States
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Augusta, Georgia, 30912, United States
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Gainesville, Georgia, 30501, United States
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McDonough, Georgia, 30253, United States
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Arlington Heights, Illinois, 60005, United States
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Bloomingdale, Illinois, 60108, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60616, United States
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Glenview, Illinois, 60026, United States
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Hazel Crest, Illinois, 60429, United States
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Park Ridge, Illinois, 60068, United States
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Springfield, Illinois, 62702, United States
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Fort Wayne, Indiana, 46845, United States
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Indianapolis, Indiana, 46202, United States
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Merrillville, Indiana, 46410, United States
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Munster, Indiana, 46321, United States
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Newburgh, Indiana, 47630, United States
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Richmond, Indiana, 47374, United States
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Davenport, Iowa, 52801, United States
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Iowa City, Iowa, 52242, United States
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West Des Moines, Iowa, 50266, United States
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Kansas City, Kansas, 66160, United States
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Edgewood, Kentucky, 41017, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40202, United States
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Hammond, Louisiana, 70403, United States
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Lafayette, Louisiana, 70503, United States
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Mandeville, Louisiana, 70448, United States
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New Orleans, Louisiana, 70121, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21215, United States
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Bethesda, Maryland, 20814, United States
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Bowie, Maryland, 20715, United States
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Columbia, Maryland, 21044, United States
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Nottingham, Maryland, 21236, United States
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Bay City, Michigan, 48708, United States
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Dearborn, Michigan, 48126, United States
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Detroit, Michigan, 48202, United States
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Kalamazoo, Michigan, 49048, United States
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Midland, Michigan, 48670, United States
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Mount Clemens, Michigan, 48043, United States
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Petoskey, Michigan, 49770, United States
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Traverse City, Michigan, 49684, United States
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Ypsilanti, Michigan, 48197, United States
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Coon Rapids, Minnesota, 55433, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55407, United States
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Minneapolis, Minnesota, 55417, United States
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Saint Cloud, Minnesota, 56303, United States
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Tupelo, Mississippi, 38801, United States
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Springfield, Missouri, 65804, United States
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St Louis, Missouri, 63103, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63136, United States
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Lincoln, Nebraska, 68506, United States
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Omaha, Nebraska, 68124, United States
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Las Vegas, Nevada, 89102, United States
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Bridgewater, New Jersey, 08807, United States
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Hackensack, New Jersey, 07601, United States
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Pomona, New Jersey, 08240, United States
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Albuquerque, New Mexico, 87102, United States
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Albany, New York, 12211, United States
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Buffalo, New York, 14203, United States
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Johnson City, New York, 13790, United States
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New York, New York, 10028, United States
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Poughkeepsie, New York, 12601, United States
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Staten Island, New York, 10310, United States
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Stony Brook, New York, 11794, United States
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The Bronx, New York, 10467, United States
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Pinehurst, North Carolina, 28374, United States
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Rocky Mount, North Carolina, 27804, United States
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Sanford, North Carolina, 27330, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27157, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44106, United States
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Springfield, Ohio, 45504, United States
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Toledo, Ohio, 43608, United States
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Allentown, Pennsylvania, 18013, United States
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Allentown, Pennsylvania, 18103, United States
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Chambersburg, Pennsylvania, 17201, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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West Reading, Pennsylvania, 19611, United States
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Wyomissing, Pennsylvania, 19610, United States
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Providence, Rhode Island, 02906, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Rapid City, South Dakota, 57701, United States
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Chattanooga, Tennessee, 37403, United States
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Greeneville, Tennessee, 37745, United States
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Jefferson City, Tennessee, 37760, United States
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Memphis, Tennessee, 38120, United States
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Oak Ridge, Tennessee, 37830, United States
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Powell, Tennessee, 37849, United States
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Amarillo, Texas, 79106, United States
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Beaumont, Texas, 77702, United States
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Corpus Christi, Texas, 78404, United States
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Cypress, Texas, 77429, United States
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Dallas, Texas, 75216, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77030-1503, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77089, United States
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Houston, Texas, 77090, United States
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Kingwood, Texas, 77339, United States
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McKinney, Texas, 75071, United States
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Mesquite, Texas, 75149, United States
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Port Arthur, Texas, 77642, United States
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San Antonio, Texas, 78207, United States
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Victoria, Texas, 77901, United States
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Waco, Texas, 76712, United States
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Newport News, Virginia, 23606, United States
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Norfolk, Virginia, 23504, United States
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Richmond, Virginia, 23219, United States
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Winchester, Virginia, 22601, United States
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Seattle, Washington, 98122, United States
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Calgary, Alberta, T1Y0B4, Canada
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Edmonton, Alberta, T6G2B7, Canada
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Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
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Burnaby, British Columbia, V5G 2X6, Canada
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Kamloops, British Columbia, V2C2T1, Canada
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North Vancouver, British Columbia, V7M 2H4, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Victoria, British Columbia, V8R 1B2, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Moncton, New Brunswick, E1C 2Z3, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Halifax, Nova Scotia, B3H3A7, Canada
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Brampton, Ontario, L6R3J7, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Kingston, Ontario, K7L2V7, Canada
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London, Ontario, N6A 5A5, Canada
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Newmarket, Ontario, L3Y 2R2, Canada
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Ottawa, Ontario, K1Y4W7, Canada
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Scarborough Village, Ontario, M1B 4Z8, Canada
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Scarborough Village, Ontario, M1B 5N1, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Granby, Quebec, J2G 1T7, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Laval, Quebec, H7M 3L9, Canada
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Lévis, Quebec, G6V 9H4, Canada
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Montreal, Quebec, H1T1C8, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H3G1A4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1R 2J6, Canada
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Québec, Quebec, G1V 4G5, Canada
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Rimouski, Quebec, G5L5T1, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Saint-Hubert, Quebec, J3Z 0C8, Canada
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Saint-Jérôme, Quebec, J7Z 2V4, Canada
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Terrebonne, Quebec, J6V 2H2, Canada
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Trois-Rivières, Quebec, G8Z 3R9, Canada
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Sherbrooke, Quebec City, J1H5N4, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Caguas, Puerto Rico, 00726, Puerto Rico
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Carolina, 00984, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Kallend, MBBS
DalCor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- With the exception of the statistician to the DSMB and the DSMB all other individuals will remain blinded until the final analysis of the primary study parameter.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2023
First Posted
June 26, 2023
Study Start
October 3, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share