Secondary Prevention of Small Subcortical Strokes Trial

Phase 3 Completed 3020 enrolled University of British Columbia National Institute of Neurological Disorders and Stroke (NINDS) · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline. On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the investigational anti platelet combination of aspirin + clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm. It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit. Also, recommended the continuation and completion of the plood pressure arm following the protocol.

Timeline

Start: 2003-02
Primary completion: 2012-04
Completion: 2012-04

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Clopidogrel	Small molecule	75 mg	—
Comparator	Aspirin	Small molecule	325 mg	—

Secondary Prevention of Small Subcortical Strokes Trial

Summary

Timeline

Publications

Drugs

Indications