GlaxoSmithKline announced initiation of the second large-scale phase-III clinical trial to evaluate long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with acute coronary syndrome (ACS). The study, called SOLID-TIMI 52 (The Stabilisation of pLaque Using darapladib -Thrombolysis In Myocardial Infarction 52), will include 11,500 patients from 40 countries.
SOLID-TIMI 52 is a randomised, placebo-controlled, double-blind trial in men and women with ACS. The study will evaluate the clinical efficacy of long-term use of darapladib as compared with placebo when both are added to standard of care (which may include a statin, aspirin and blood pressure medications). The study will test whether darapladib affects the chances of having a cardiovascular event, such as a heart attack or stroke, when treatment is started within 30 days after an acute coronary syndrome.
“Because cardiovascular disease remains the world’s number one killer, new approaches to treatment are needed. Targeting and inhibiting the Lp-PLA2 enzyme may reduce the risk of cardiovascular events in patients with heart disease,” said Patrick Vallance, senior vice president, Drug Discovery, GlaxoSmithKline. “With more than 27,000 patients, the combined phase-III clinical programme for darapladib will be one of the largest ever conducted to evaluate the efficacy and safety of any cardiovascular medication.”
SOLID-TIMI 52 is the second pivotal phase-III trial to evaluate darapladib. The first large-scale trial, Stability, is studying darapladib in patients with chronic coronary artery disease. Stability was initiated in late 2008 and has completed enrolment ahead of schedule with more than 15,000 patients recruited.
In SOLID-TIMI 52, men and women with ACS and receiving standard of care will be randomised 1:1 to once-daily doses of darapladib 160 mg enteric-coated tablets or placebo.
Darapladib is a selective and orally active inhibitor of LpPLA2 currently in phase-III development as a potential anti-atherosclerosis agent.