Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Status:
Recruiting
Trial end date:
2027-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
DalCor Pharmaceuticals
Collaborator:
The Montreal Health Innovations Coordinating Center (MHICC)