The National Institute of Neurological Disorders and Stroke has stopped a stroke prevention study prior to completion. This is the second study this year which has been halted early by its data safety monitoring board (DSMB). Medical studies have a board which monitors the study to determine whether there are any problems, or whether the preliminary data suggest issues that would make it unethical to continue.
The SPS3 trial is being conducted to learn about preventing a second stroke in patients who have suffered a type of small stroke generally related to hypertension and other factors. The study was designed to test whether two types of interventions would lower the risk of a recurrent stroke; treatment of blood pressure, and use of whether a combination of aspirin and clopidogrel (Plavix) would be better than aspirin alone. Over 3,000 patients were entered into this trial.
The data safety monitoring board suggested that the component of the study related to aspirin and clopidogrel be stopped. Patients on the combination of aspirin and clopidogrel had more bleeding, and did not demonstrate benefit according to the current data.
According to the press release from the NINDS, these results support current guidelines that recommend against the use of the combination of clopidogrel plus aspirin for stroke prevention, and extend this advise to those with small strokes that have been demonstrated by MRI.
What does this mean to clinical practice. It once again demonstrates that the best ways to prevent stroke appear to be the control of risk factors, such as high blood pressure, diabetes, and smoking.