Antithrombotic outcome trials in acute coronary syndromes: seeking the optimal balance between safety and efficacy

This article highlights key points from discussions around antithrombotic drug development for acute coronary syndromes (ACS) that took place during the 7th and 8th Global Cardiovascular Clinical Trialists (CVCT) forums in December 2010 and 2011.   The following are discussed:   . Dose selection . Phase II designs and endpoints . Reporting bleeding risks . Determining therapeutic benefit and risk profiles . Challenges facing future trials   In the conclusion, the authors comment that: "Previous advances in ACS management have reduced event rates such that mega-trials involving tens of thousands of patients are now required to achieve sufficient power to detect relatively small treatment effects. This necessitates the use of composite efficacy and safety endpoints, so that adequate numbers of events can accrue in a reasonable time frame. Investigators, regulators, and physicians are then faced with the ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news