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Acute Coronary SyndromeGeneticsDrugPhase 3

What this study is

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.

What's being tested

  • Dalcetrapib

    Intervention · DRUG

    Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets

  • Placebo

    Intervention · DRUG

    matching placebo tablets

Study details

Official title
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)
Sponsor
DalCor Pharmaceuticals
Conditions
Acute Coronary Syndrome
Enrolling
2,000 people
Starts
2023-10-03
Est. completion
2027-08
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗