Plavix-Aspirin Arm of Stroke Study Halted Following High Incidence of Bleeding Events

The <"">Plavix-aspirin arm of a stroke prevention clinical trial has been halted, after an unexpectedly-high number of patients receiving the drug combo suffered a bleeding event. There were also more deaths in the study’s Plavix-aspirin group compared to the aspirin-only group. At the same time, the study was unable to show that the Plavix-aspirin combination would provide a significant benefit in stroke prevention.

The study in question is called SPS3 for “Secondary Prevention of Small Subcortical Strokes.” According to a report from The Wall Street Journal, the study, which should be completed next April, was being conducted by the National Institute of Neurological Disorders and Stroke (NINDS). It was designed to determine if Plavix-aspirin therapy could prevent recurring strokes in people who had recently suffered “subcortical” strokes, which occur in the small blood vessels of the brain. Such strokes, though milder than others types, can reoccur and damage to the brain can build up over time. People who suffer subcortical strokes are predisposed to dementia, the Journal said.

According to the Journal, the study started in 2003, and involved 3,000 people. NINDS halted an arm of the study after the data-safety monitoring board found 6.5% of patients on Plavix-aspirin therapy 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 Plavix-aspirin combination is approved to prevent future heart attacks, strokes and other cardiovascular events in people with acute coronary syndrome. The Journal pointed out that the Plavix prescribing label already notes that its use with aspirin in people with recent stroke has been linked to increased risk of bleeding. It further states that Plavix-aspirin therapy does not offer any additional benefit over Plavix alone in people with recent stroke.

According to the Journal, the arm of the study testing whether blood-pressure medications can prevent strokes and cognitive decline will continue.

As we’ve reported, Plavix is the subject of lawsuits alleging its makers failed to adequately research the medication or warn about the risks which could increase the likelihood of serious and potentially life-threatening complications. Recently, dozens of Plavix injury lawsuits were centralized in New Jersey and transferred to Superior Court Judge Jessica R. Mayer in Middlesex.

Recent studies lend support to plaintiffs’ allegations. For example, one study conducted by the U.S. Centers for Disease Control (CDC) that compared the blood thinner, Wafarin, with combination Plavix-aspirin therapy found the risk of hemorrhaging in people treated with the Plavix combo was significantly higher than previously believed. Another study published in the New England Journal of Medicine found that patients taking Plavix are 12 times likelier to suffer recurrent ulcers and gastrointestinal bleeding than those who received a combination of aspirin and a heartburn pill.

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