MedTrace Logo

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

NCT05918861 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Dalcetrapib

Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets

DRUG

Placebo

matching placebo tablets

Sponsors & Collaborators

  • The Montreal Health Innovations Coordinating Center (MHICC)

    collaborator OTHER

  • DalCor Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Kallend, MBBS · DalCor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918861 on ClinicalTrials.gov