Phase 3
Completed N=6,147
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Acute Coronary Syndrome
Source: ClinicalTrials.gov NCT02525939 ↗
Enrolled (actual)
6,147
Serious AEs
29.7%
Results posted
Oct 2022
Primary outcomePrimary: Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke — 327; 292 Participants — p=0.12
◆ Published Evidence
Established
39citations · ~10 / year
Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial.
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.
Linked Publications (3)
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Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial.
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Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib.
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Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke |
327; 292 | 0.12 |
| SECONDARY 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 |
471; 471 | 0.95 |
| SECONDARY Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure |
346; 321 | 0.27 |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT02525939) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.