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Tracking Information | |||||||||
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First Received Date ICMJE | April 23, 2003 | ||||||||
Last Updated Date | September 20, 2011 | ||||||||
Start Date ICMJE | February 2003 | ||||||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00059306 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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. [ Time Frame: within mean follow-up of 4 years ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures ICMJE |
The difference in the rate of cognitive decline among SPS3 participants assigned to received aspirin alone versus combination of aspirin and clopidogrel, assessed through repeated neuropsychological tests. [ Time Frame: within mean follow-up of 3 years ] [ Designated as safety issue: No ] | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Secondary Prevention of Small Subcortical Strokes Trial | ||||||||
Official Title ICMJE | Secondary Prevention of Small Subcortical Strokes (SPS3) Trial | ||||||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 3000 | ||||||||
Estimated Completion Date | April 2012 | ||||||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | INCLUSION: Small subcortical ischemic stroke or subcortical TIA. Inclusion criteria are based on TOAST criteria supplemented by required MRI data. All of the following criteria must be met:
EXCLUSION: To be eligible for entry into the study, the patient must not meet any of the criteria listed below:
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Gender | Both | ||||||||
Ages | 30 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States, Canada, Chile, Ecuador, Mexico, Peru, Spain | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00059306 | ||||||||
Other Study ID Numbers ICMJE | R01NS38529, CRC | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | University of British Columbia | ||||||||
Study Sponsor ICMJE | University of British Columbia | ||||||||
Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
Investigators ICMJE |
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Information Provided By | University of British Columbia | ||||||||
Verification Date | September 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |