Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 5000
Summary
- Conditions
- Acute Coronary Syndrome
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT02525939
- Collaborators
- The Montreal Health Innovations Coordinating Center (MHICC)
- Medpace, Inc.
- Roche Molecular Systems, Inc
- Investigators
- Study Director: Donald M Black, MD DalCor Pharmaceuticals
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