Dalcetrapib for Heart Attack Risk in a Specific Genetic Group

This study is looking at whether a drug called dalcetrapib can reduce the risk of future heart problems in people who have recently had a heart attack (acute coronary syndrome or ACS). You could be eligible if you are at least 45 years old, have recently been hospitalized for ACS, and have a specific genetic marker called the AA genotype in the ADCY9 gene. This genetic marker will be checked with a special test. The study compares dalcetrapib (300 mg tablets) to a placebo (a pill with no medicine) to see if dalcetrapib can lower the chance of having another heart attack or a fatal heart event. The study aims to enroll 2000 participants, but its current status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either dalcetrapib or a placebo, and neither you nor your doctor will know which you are receiving. It is a large study aiming for 2000 participants.
What's involved
You will have virtual or clinic visits every 3 months after randomization until the study ends. If you stop taking the study medication early, assessments will continue every 3 months.
Compensation
Not stated in the trial record.
Follow-up
The study will track your health until approximately 200 participants experience a primary event, with the main outcome measured at an average of 30 months from when you start.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05918861

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

Recruiting
PHASE3Ages 45+InterventionalTreatment
DalCor Pharmaceuticals
~2,000 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:DalcetrapibPlacebo

At a glance

Recruiting sites
157 of 231 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)
Measured over Average of 30 months from randomization
Acute Coronary Syndrome

NCT05918861

Where you'd take part

This study runs at 231 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Birmingham, Alabamano site contact published

    Recruiting

  • Research Site

    Fairhope, Alabamano site contact published

    Recruiting

  • Research Site

    Huntsville, Alabamano site contact published

    Recruiting

  • Research Site

    Mobile, Alabamano site contact published

    Recruiting

  • Research Site

    Scottsdale, Arizonano site contact published

    Recruiting

  • Research Site

    Tucson, Arizonano site contact published

    Recruiting

  • Research Site

    North Little Rock, Arkansasno site contact published

    Recruiting

  • Research Site

    Huntington Beach, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • David Kallend, MBBS · STUDY_DIRECTOR · DalCor

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)Average of 30 months from randomization

    Time to patients experiencing major cardiovascular events