Secondary Prevention of Small Subcortical Strokes Trial
Completed · Phase 3 · Has a placebo group
Conditions studied: Cerebrovascular Accident, Hypertension
In brief
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.
Key facts
- Study ID
- NCT00059306
- Run by
- University of British Columbia
- People needed
- 3020
- Starts
- 2003-02-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2013-04-04
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Catholic Healthcare West — Phoenix, Arizona, United States
- Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
- University of Arizona, Department of Neurology — Tucson, Arizona, United States
- University of California San Diego Medical Center — San Diego, California, United States
- University of California San Francisco-Fresno — San Francisco-Fresno, California, United States
- Denver — Englewood, Colorado, United States
- Melbourne — Melbourne, Florida, United States
- Miami-University of Miami, Miller School of Medicine — Miami, Florida, United States
- Emory University, Grady Health System — Atlanta, Georgia, United States
- Mercy Medical Center-Ruan Neurology Clinical Research — Des Moines, Iowa, United States
- University of Kentucky, Aging/Stroke Program — Lexington, Kentucky, United States
- Suburban Hospital — Bethesda, Maryland, United States
- Boston University — Boston, Massachusetts, United States
- Wayne State — Detroit, Michigan, United States
- Henry Ford Hospital, Department of Neurology — Detroit, Michigan, United States
- Berman Center — Minneapolis, Minnesota, United States
- Mayo Stroke Center KA-SL-13 — Rochester, Minnesota, United States
- University of Washington — Sant Louis, Missouri, United States
- Tenet Health, St. Louis University — St Louis, Missouri, United States
- St. John's Mercy — St Louis, Missouri, United States
- Cooper University Hospital — Camden, New Jersey, United States
- Buffalo — Buffalo, New York, United States
- Helen Hayes Hospital — Haverstraw, New York, United States
- Columbia University Medical Center — New York, New York, United States
- University of Southern Alabama Stroke Center — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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