Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS - Trial NCT05918861
Access comprehensive clinical trial information for NCT05918861 through Pure Global AI's free database. This Phase 3 trial is sponsored by DalCor Pharmaceuticals and is currently Not yet recruiting. The study focuses on Acute Coronary Syndrome. Target enrollment is 2000 participants.
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Study Focus
Sponsor & Location
DalCor Pharmaceuticals
Timeline & Enrollment
Phase 3
Jun 01, 2023
Aug 01, 2027
Primary Outcome
Time to first occurrence of any fatal or non-fatal MI
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05918861
Non-Device Trial