Dal-GenE-2

Full Clinical Trial Name

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 recent Acute Coronary Syndrome (ACS): The DAL-302 (dal-GenE-2) trial

Clinical Trial

  • Heart and Vascular

Phase

Phase
3

Patient Type

Adult
Doctor(s) running this study
Eric E. Elgin, MD
Location(s):
Call 610-402-9543
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Purpose

The objective of this trial is to evaluate the potential of dalcetrapib, an oral medication, to reduce the occurrence of myocardial infarction (AKA heart attack) in participants with a recent acute coronary syndrome event. Participants will be screened to determine if they have the AA genotype variant to be eligible for this study. 

Description

Coronary heart disease (CHD) is a major contributor to mortality, affecting a wide range of individuals. CHD can be influenced by many factors, including genetics, smoking, high blood pressure, and altered plasma lipids. Specifically, the elevation of LDL-C and decreased HDL-C have been linked to developing CHD. The medication for this study, dalcetrapib, is a cholesterol ester transfer protein (CETP) inhibitor that may prove to have cardio-protective properties for those with CHD.

The Dal-GenE-2 study has been called one of the first “precision treatments” for reducing the risk of myocardial infarction in a defined population. To be eligible for this study, genetic screening must be performed to determine if the AA genotype variant at rs1967309 is present. Dalcetrapib has shown in previous studies to reduce the risk of reoccurrence of a coronary event by up to 40% in those with an AA genotype variant.

Eligibility

Inclusion Criteria
  • AA genotype at variant rs1967309
  • Recent acute coronary event with detection of rise and fall of cardiac biomarkers
  • Procedure related myocardial infarction (MI) after percutaneous coronary intervention (PCI)
  • Must be clinically stable and free of symptoms for at least one week prior to beginning study drug

Learn more about the full clinical trial

Full description at clinicaltrials.gov

Doctor(s) running this study