A 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): The Dal-GenE Trial

DalGenE [NCT02525939]

Description: DAL-301: 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.

Drug: dalcetrapib; Drug: Placebo

Primary Investigator: Kereiakes

Drug/Device Information
To evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene
Dalcetrapib is a compound selected for its capacity to modulate plasma CETP activity and increase HDL-C levels
Subjects must be randomized between 4 and 12 weeks from the index event
Randomized to 600 mg of dalcetrapib or placebo in a 1:1 ratio
DalCor Pharma UK Ltd