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NCT00576693 · ClinicalTrials.gov registry record · Phase 3
Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis
A Phase 3 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
NCT00576693 is a Phase 3 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 451 participants.
The verdict
NCT00576693, a Phase 3 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
Study Summary
PRIMARY HYPOTHESIS: Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial stenosis who had a transient ischemic attack (TIA) or stroke within 30 days prior to enrollment) with symptomatic stenosis of a major intracranial artery. SUMMARY: The best treatment for prevention of another stroke or TIA in patients with narrowing of one of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting medications to prevent blood clots from forming in the narrowed vessel. There are a variety of medicines used for this purpose. These medications are usually taken for the rest of a patient's life. However, a treatment that has been used successfully together with anti-clotting medications in patients with narrowing of the blood vessels of the heart is now being studied in the blood vessels of the brain. This treatment is called stenting. Recent research has also indicated a benefit in prevention of recurring stroke by Intensive Medical Therapy, which is defined as treating risk factors for stroke like high blood pressure, elevated LDL (low density lipids - the "bad" form of cholesterol) and diabetes. The purpose of this study is to compare the safety and effectiveness of either Intensive Medical Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks or death. The study will enroll patients over a 5 year period. Each participant will be involved in the study for a minimum of 1 year and a maximum of 3 years. Fifty different medical centers in the United States are part of this study. Both the Clinical Coordinating Center and the Statistical Coordinating Center for the entire study will be located at Emory University.
Interventions
- OTHER intensive medical management
- DEVICE intracranial angioplasty and stenting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2008-10 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00576693
The ClinicalTrials.gov registry entry for NCT00576693 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 451 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which intensive medical management is the first listed.
NCT00576693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00576693 about?
NCT00576693 is a clinical study titled "Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis". PRIMARY HYPOTHESIS: Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial stenos...
What is the current status of trial NCT00576693?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2008-10. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00576693?
The interventions under investigation include: intensive medical management (OTHER), intracranial angioplasty and stenting (DEVICE).
Who is sponsoring clinical trial NCT00576693?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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