Based on the recommendation of the steering committee for the ACHIEVE (An Assessment of Coronary Health Using an Intima-Media Thickness Endpoint for Vascular Effects) trial, Merck is halting further patient enrollment in the study.
The action will allow the steering committee to evaluate the current study design in light of scientific data from recent intima-media thickness (IMT) studies, according to Kenilworth, N.J.-based Merck.
The company also recommended that ongoing clinical studies with Merck's investigational extended-release niacin/laropiprant (Cordaptive), including the 20,000 patient outcomes study known as HPS2-THRIVE, continue unchanged.
“Since ACHIEVE was originally designed, the understanding of carotid IMT studies has evolved leading the committee to decide to take this action," said John Kastelein, MD, chair of the ACHIEVE Steering Committee, Academisch Medisch Centrum in Amsterdam, The Netherlands.
The committee expects to meet in the near future to review additional analyses and options, and advise on a path forward for ACHIEVE.
“In the meantime, patients currently enrolled in ACHIEVE will continue to be followed according to the protocol and all study data will remain blinded,” said Christie Ballantyne, MD, chief of atherosclerosis and vascular medicine at Baylor College of Medicine and the Methodist DeBakey Heart Center; both located in Houston.
Merck said it has begun to notify study investigators and regulatory agencies of the decision.
ACHIEVE, which is underway in 17 countries, is a study designed to evaluate the effects of Cordaptive on carotid IMT in patients with familial hypercholesterolemia. The study was initiated in October 2006 and approximately one-third of the planned 900 patients are currently enrolled.