deCODE genetics has announced the initiation of patient enrollment in the pivotal Phase III trial for DG031, the company's lead developmental compound for the prevention of heart attack.
The multicenter trial will be randomized, double-blind, placebo-controlled, and will enroll 3400 patients with a history of recent heart attack. The trial, the Leukotrienes in Coronary Artery Disease, or LTCAD study, will focus on the group at highest identifiable risk of heart attack through the pathway targeted by DG031: African-American heart patients who carry an at-risk variant of one of the genes deCODE has linked to risk of heart attack through the leukotriene pathway.
The trial will also include patients without the at-risk variant. The trial will evaluate a dose of 500mg of DG031 twice daily, and the primary endpoint is a composite of reduction in fatal and non-fatal heart attack and stroke, hospitalization for unstable angina, and the need for urgent revascularization. The duration of the trial will be driven by the number of cardiac events seen in the study group.