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NCT05918861Not yet recruiting

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

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)
DalCor PharmaceuticalsPhase 3ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
Dalcetrapib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
DalCor Pharmaceuticals
Location
Alexander City,Huntsville,Mobile,Torrance,Littleton,Clearwater,Fort Lauderdale,Largo,Pembroke Pines,Pensacola,Safety Harbor,Tallahassee,Newburgh,West Des Moines,Bangor,Bethesda,Midland,Ypsilanti,Coon , Canada,United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Jun 01, 2023
End date
Aug 01, 2027
Enrollment
2000 participants
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
Acute myocardial infarctionAcute myocardial infarction, unspecifiedAcute subendocardial myocardial infarctionAcute ischaemic heart disease, unspecifiedOther acute ischaemic heart diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05918861
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.