Plavix Trial Halted Over Bleeding


A Plavix clinical trial was recently halted by the National Institute of Neurological Disorders and Strokes (NINDS) over bleeding concerns. The stroke prevention study was ceased by the governmental institute because the Plavix-aspirin combination proved more dangerous and deadly than just aspirin. The study—SPS3—is entitled “Secondary Prevention of Small Subcortical Strokes.”

The study, which involved 3,000 patients, was funded by NINDS, which issued the clinical advisory in September discussing the early end to the Plavix-aspirin aspect of the research, said The Wall Street Journal. The study was initiated in 2003 and was researching if the Bristol-Myers Squibb Co. and Sanofi SA’s blood thinner, Plavix, when taken with aspirin, could stop so-called “subcortical” strokes, said the Journal. Subcortical strokes are recurring strokes that occur in patients who suffered recent strokes in the brain’s small vessels.

The action was taken after a data-safety monitoring board discovered, this summer, that 6.5% of all patients taking Plavix and aspirin experienced some type of bleeding event, versus 3.3% of those only taking aspirin, said the Journal. In the combination group, there were more deaths than in the aspirin-only group: 5.8% versus 4.1%. The research also revealed that, should the study have continued, the combination therapy offered no real significant benefit in stroke prevention, noted the Journal.

“For stroke … the combination does not offer any protection, but does put you at increased risk for bleeding,” said Walter Koroshetz, deputy director of NINDS, reported the Journal. Koroshetz also pointed out that the findings are in line with prevailing medical guidelines, which recommend not using the combination for secondary stroke prevention, citing prior studies, said the Journal, which noted that the suggestion now includes recent sufferers of subcortical strokes.

The Plavix-aspirin combination is approved for future heart attack, stroke, and cardiovascular events in people who suffer from acute coronary syndrome, said the Journal; that approval remains. The syndrome involves chest pain connected with heart attack or unstable angina. The part of the study reviewing if blood-pressure drugs can prevent strokes and cognitive decline, will continue.