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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

The dal-GenE trial is evaluating the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with a documented recent heart attack or hospitalization due to severe coronary artery disease. Dalcetrapib is an investigational drug (not approved by the United States Food and Drug Administration) that has been evaluated in several large clinical trials, most notably dal-OUTCOMES, a study of over 15,000 patients which was designed to evaluate its effect in patients with recent ACS. The results of this large study demonstrated that treatment with dalcetrapib did not change the risk of cardiovascular disease in the majority of patients with recent ACS. However, after the study was over, researchers identified a group of patients that had a significant benefit. Specifically, the group of patients who had a particular variant (AA) of a gene that all humans share (ADCY9) had their risk of having another cardiovascular event reduced by 39%. Approximately 1 in 5 patients studied had this genetic variant. Those individuals with the AA variant of the will continue in the study and will be started on study drug 4-12 weeks after their index event.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Male or female age 45 or greater
Admitted to hospital due to blockages in arteries of the heart
Exclusion Criteria:
Bypass surgery to treat your most recent heart event
Severe liver and/or kidney disease
Hemoglobin A1c greater than 10%
Triglyceride level greater than 500mg/dL
Heart & Vascular
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Hershey, PA