Secondary Prevention of Small Subcortical Strokes Trial

Phase 3

Completed

• Conditions: Cerebrovascular Accident; Hypertension
• Interventions: Drug: aspirin; Other: Target of Blood Pressure; Drug: clopidogrel; Other: placebo

• 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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-04-23
• Study First Submitted QC: 2003-04-23
• Study First Posted: 2003-04-24
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3020

Inclusion Criteria

Not provided

Exclusion Criteria

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)

University of Southern Alabama Stroke Center; 🇺🇸 Mobile, Alabama, United States

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

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