GlaxoSmithKline (GSK) has initiated the first pivotal Phase III clinical trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with chronic coronary heart disease (CHD).
The randomized, placebo-controlled, double-blind, parallel group multi-center study, STABILITY (STabilization of Atherosclerotic plaque By Initiation of darapLadIb TherapY), will include more than 15,000 patients with chronic CHD from 39 countries.
The London-based GSK said the study will evaluate the clinical efficacy of long-term treatment with darapladib as compared with placebo (when both are added to standard of care which may include a statin, aspirin and blood pressure medications) on the incidence of first occurrence of major adverse cardiovascular events, including CV death, non-fatal MI and non-fatal stroke.
“The recently completed IBIS-2 study (Integrated Biomarker and Imaging Study-2) showed that use of darapladib reduced Lp-PLA2 activity in plasma and prevented expansion of the necrotic core,” said Harvey White, MD, co-chair of the steering committee for STABILITY and director of coronary care and cardiovascular research unit at Auckland City Hospital in Auckland, New Zealand. “STABILITY will help us to determine whether treatment with darapladib is in fact associated with favorable effects on these outcomes, as well as stroke.”