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Higher Rate of Bleeding, Death Halts Plavix Study

Feb 6, 2012 | Parker Waichman LLP

After patients in a stroke prevention study on Plavix-aspirin therapy suffered a higher-than-expected number of bleeding events compared to subjects taking aspirin alone, that arm of the study was shut down.  According to a press release from the American Heart Association, patients in the study treated with the Plavix-aspirin combo also suffered a higher death rate compared to those on aspirin only.  The study was presented last week at the American Heart Association’s International Stroke Conference 2012,

According to the study, 6.5% of patients on Plavix-aspirin therapy combination experienced a bleeding event, versus 3.3% of those on aspirin alone.  The death rate among people in the combo therapy group was 5.8% versus 4.1% in the aspirin-only group.

The study, "Secondary Prevention of Small Subcortical Strokes," or SPS3, was being conducted by the National Institute of Neurological Disorders and Stroke (NINDS).    The Plavix-Aspirin arm involved 3,000 patients.  The aim of the clinical trial was determine if Plavix-aspirin therapy could prevent recurring strokes in people who had recently suffered "subcortical" strokes.  According to the Journal, such strokes, though usually mild, can reoccur and damage the brain over time, predisposing sufferers to dementia.

In addition to the higher bleeding and death rates, the Plavix-aspirin arm of the study was unable to demonstrate that combo therapy provided any additional benefit in preventing strokes.

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