Secondary Prevention of Small Subcortical Strokes Trial
- Conditions
- Cerebrovascular AccidentHypertension
- Interventions
- Registration Number
- NCT00059306
- Lead Sponsor
- University of British Columbia
- Brief 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.
- Detailed Description
Stroke is damage to the brain caused by problems in the blood vessels. Strokes often cause paralysis, loss of sensation and speech, and other problems. A lacunar or small Subcortical stroke affects the inner part of the brain causing small "pea sized" areas of damage due to blockage of small blood vessels within the brain.
This multi-center study will recruit 3000 participants (20 percent of whom will be Hispanic) to find out if using aspirin and clopidogrel is more effective than using aspirin alone to prevent recurrent stroke in patients with lacunar stroke confirmed by MRI, and if lowering a patient's blood pressure below the usual limits will also help prevent recurrent stroke and maintain thinking ability. Both aspirin and clopidogrel are widely-used for blood clotting and stroke prevention. Investigators intend to find out if using the drugs together is more effective than using aspirin alone.
Participants will be randomly assigned to one of 2 types of treatment: either aspirin alone or the combination of aspirin and clopidogrel. In addition, participants will be assigned to one of 2 groups of blood pressure control. The difference between the two groups is the target level of systolic blood pressure-either 130-149 or below 130. The goal of the blood pressure aspect of this trial is to find out if lowering blood pressure after stroke helps to prevent recurrent stroke and preserves cognition.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3020
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antiplatelet aspirin Participants receive aspirin + placebo OR aspirin + clopidogrel Antiplatelet placebo Participants receive aspirin + placebo OR aspirin + clopidogrel Blood pressure Target of Blood Pressure The goal of the blood pressure aspect of this trial is to find out if lowering blood pressure after stroke helps to prevent recurrent stroke and preserves cognition. Antiplatelet clopidogrel Participants receive aspirin + placebo OR aspirin + clopidogrel
- Primary Outcome Measures
Name Time Method Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. within mean follow-up of 4 years Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI Mean follow up of 4 years
- Secondary Outcome Measures
Name Time Method The difference in the rate of cognitive decline among SPS3 participants assigned to receive aspirin alone versus combination of aspirin and clopidogrel, assessed through repeated neuropsychological tests; and major vascular events. within mean follow-up of 4 years
Trial Locations
- Locations (62)
Ohio State University, Division of Stroke
🇺🇸Columbus, Ohio, United States
Marshfield Clinic, Department of Neurology
🇺🇸Marshfield, Wisconsin, United States
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Miami-University of Miami, Miller School of Medicine
🇺🇸Miami, Florida, United States
Berman Center
🇺🇸Minneapolis, Minnesota, United States
Calgary Health
🇨🇦Calgary, Alberta, Canada
Rochester General Hospital
🇺🇸Rochester, New York, United States
McGill-Montreal General
🇨🇦Montreal, Quebec, Canada
University of Arizona, Department of Neurology
🇺🇸Tucson, Arizona, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
McGill-Jewish General
🇨🇦Montreal, Quebec, Canada
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zuibrán
🇲🇽Mexico City, Mexico
Catholic Healthcare West
🇺🇸Phoenix, Arizona, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Henry Ford Hospital, Department of Neurology
🇺🇸Detroit, Michigan, United States
Hospital Del Mar, Passeig Marítim 25-29
🇪🇸Barcelona, Spain
Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
🇲🇽Mexico City, Mexico
Hosp. de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital del Sagrat Cor. Quinta de Salut I'Alianca, c/Viladomat 288
🇪🇸Barcelona, Spain
Hosp. Universitario Germans Trias I Pujol
🇪🇸Badalona, Spain
Hosp. Parc Tauli de Sabadell
🇪🇸Barcelona, Spain
Hospital Sabogal Essalud-Unidad de Investigacion
🇵🇪Bellavista-Callao, Lima, Peru
Universidad de Santiago de Compostela, Facultad de Medicina y Odontologia
🇪🇸Santiago de Compostela, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital de la Santa Creu I Sant Pau, c/Sant Antoni Maria Claret, 167
🇪🇸Barcelona, Spain
Hospital Clinico de la Universidad Católica de Chile
🇨🇱Santiago, Chile
Hospital Naval Almirante Nef, 'Subida Alessandri s/n, Hall A, Oficina 9
🇨🇱Viña del Mar, Chile
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Denver
🇺🇸Englewood, Colorado, United States
Melbourne
🇺🇸Melbourne, Florida, United States
Mercy Medical Center-Ruan Neurology Clinical Research
🇺🇸Des Moines, Iowa, United States
Emory University, Grady Health System
🇺🇸Atlanta, Georgia, United States
University of Kentucky, Aging/Stroke Program
🇺🇸Lexington, Kentucky, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Wayne State
🇺🇸Detroit, Michigan, United States
Mayo Stroke Center KA-SL-13
🇺🇸Rochester, Minnesota, United States
Tenet Health, St. Louis University
🇺🇸St. Louis, Missouri, United States
St. John's Mercy
🇺🇸St. Louis, Missouri, United States
Buffalo
🇺🇸Buffalo, New York, United States
Helen Hayes Hospital
🇺🇸Haverstraw, New York, United States
University of California San Francisco-Fresno
🇺🇸San Francisco-Fresno, California, United States
Boston University
🇺🇸Boston, Massachusetts, United States
University of Washington
🇺🇸Seattle, Washington, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Case Western
🇺🇸Cleveland, Ohio, United States
Hospital de La Universidad Autonoma de Nuevo Leon
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital-Clinica Kennedy
🇪🇨Guayaquil, Ecuador
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin-Neurology
🇺🇸Milwaukee, Wisconsin, United States
Antiguo Hospital Civil de Guadalajara
🇲🇽Guadalajara, Mexico
SPS3 Coordinating Center
🇨🇦Vancouver, British Columbia, Canada
Halifax
🇨🇦Halifax, Nova Scotia, Canada
Ottawa Hospital General Campus
🇨🇦Ottawa, Ontario, Canada
Greenfield Park
🇨🇦Greenfield Park, Quebec, Canada
CHA-Hospital de l'Enfant-Jesus
🇨🇦Quebec City, Quebec, Canada
Wake Forest University, Sciences-Neurology
🇺🇸Winston-Salem, North Carolina, United States
Scurlock Stroke Center
🇺🇸Houston, Texas, United States
University of Southern Alabama Stroke Center
🇺🇸Mobile, Alabama, United States