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Bleeding warning in Merck drug trial

Merck has published details of safety recommendations made as a result of an increased risk of bleeding in stroke patients involved in clinical trials of vorapaxar

Merck has published details of safety recommendations made by the Data and Safety Monitoring Board (DSMB) in relation to the clinical trial of vorapaxar, an investigation cardiovascular therapy. The recommendations relate to changes in two large clinical studies of vorapaxar (TRA-2P and TRACER) as a result of safety and efficacy data pointing to an increased risk of bleeding on patients with a history of stroke.

Dr Eugene Braunwald, chairman of the TRA-2P study, reported to investigators that: "The DSMB has communicated to us that based on all of the data (safety and efficacy) available to them from both trials, they recommend that subjects with a history of stroke not receive vorapaxar. They have observed an increase in intracranial haemorrhage in patients with a history of stroke that is not outweighed by their considerations of potential benefit."

The two major clinical endpoint trials to evaluate vorapaxar for the prevention of cardiac events are: TRA-2P (also known as TIMI 50), a study in patients with prior heart attack, stroke and peripheral artery disease, and TRACER, a study in patients with acute coronary syndrome.

Commenting on the new communication, Dr Braunwald said, "In contrast, on the basis of their risk/benefit assessment in patients without a history of stroke, the DSMB recommended to us that it is important that the trial continue to completion in the more than 20,000 subjects who qualified for the trial with myocardial infarction or peripheral arterial disease who have not had a stroke. On the basis of their recommendation, we and Merck remain committed to completing this important scientific investigation with a potential for a reduction in death and ischaemic events in these patients."

20th January 2011

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