NCT02525939

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

A 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): The Dal-GenE Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,147 (actual)
• Sponsor: DalCor Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an event driven study to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 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. The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	dalcetrapib	Cholesterol Ester Transfer Protein inhibitor
DRUG	Placebo	matching placebo tablets

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2015-08-18
• Last updated: 2022-10-12
• Results posted: 2022-10-12

Locations

557 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), United Arab Emirates, United Kingdom