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NCT00059306 · ClinicalTrials.gov registry record · Phase 3
Secondary Prevention of Small Subcortical Strokes Trial
A Phase 3 study, sponsored by University of British Columbia.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,020
- Enrollment target
NCT00059306 is a Phase 3 study that has completed, run by University of British Columbia. The registered enrollment target is 3,020 participants.
The verdict
NCT00059306, a Phase 3 study, has completed, sponsored by University of British Columbia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,020 participants
- Enrollment target
Study 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.
Interventions
- OTHER placebo
- DRUG aspirin
- DRUG clopidogrel
- OTHER Target of Blood Pressure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,020 participants |
| Start Date | 2003-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059306
The ClinicalTrials.gov registry entry for NCT00059306 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,020 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of British Columbia, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00059306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059306 about?
NCT00059306 is a clinical study titled "Secondary Prevention of Small Subcortical Strokes Trial". 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...
What is the current status of trial NCT00059306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,020 participants. The study started on 2003-02. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00059306?
The interventions under investigation include: placebo (OTHER), aspirin (DRUG), clopidogrel (DRUG), Target of Blood Pressure (OTHER).
Who is sponsoring clinical trial NCT00059306?
This trial is sponsored by University of British Columbia, which has 18 total clinical trials registered on ClinicalTrials.gov.
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