NCT05918861

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: DalCor Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints. Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Dalcetrapib	Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
DRUG	Placebo	matching placebo tablets

Timeline

• Start date: 2023-10-03
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2023-06-26
• Last updated: 2026-01-07

Locations

223 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study