Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Status:
Active, not recruiting
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
DalCor Pharmaceuticals
Collaborators:
Medpace, Inc. Roche Molecular Systems, Inc The Montreal Health Innovations Coordinating Center (MHICC)