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NCT00046293 · ClinicalTrials.gov registry record · Phase 2
ReoPro and Retavase to Treat Acute Stroke
A Phase 2 study of Cerebrovascular Accident, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 3
- Study locations
NCT00046293 is a Phase 2 study of Cerebrovascular Accident that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 72 participants, below the 515-participant average among 26 other Cerebrovascular Accident trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT00046293, a Phase 2 study of Cerebrovascular Accident, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will determine the dose of Retavase that can safely be combined with ReoPro in treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and Retavase are currently approved by the Food and Drug Administration to treat heart problems caused by blockage of heart arteries. The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is effective only if begun within 3 hours of onset of the stroke, however, and most patients do not get to the hospital early enough to benefit from it. Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to obtain images of the brain. The patient lies on a table that is moved into a cylindrical machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes. All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is infused into the vein over 12 hours. Some patients will also receive one of four doses of Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel. Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments will include physical examinations, blood tests to examine factors involved in blood clotting, and CT scans to evaluate both the response to treatment and drug side effects. They will return for a follow-up examination and CT scan 30 days after treatment. ...
Conditions Studied
Interventions
- DRUG Reopro
- DRUG Retrovase
Study Locations (3)
Maryland
- Suburban Hospital - Bethesda
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2002-09-24 |
| Est. Completion | 2007-07-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00046293
The ClinicalTrials.gov registry entry for NCT00046293 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 515-participant average among 26 other Cerebrovascular Accident trials with a reported enrollment target (86% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cerebrovascular Accident appearing as the primary indexed condition, and to 2 interventions - of which Reopro is the first listed.
NCT00046293 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Maryland, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00046293 about?
NCT00046293 is a clinical study titled "ReoPro and Retavase to Treat Acute Stroke". This study will determine the dose of Retavase that can safely be combined with ReoPro in treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and Retavase are currently approved by the Food and Drug Administration to treat heart problems caused by blockage of hea...
What is the current status of trial NCT00046293?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2002-09-24. Estimated completion is 2007-07-20.
What conditions does trial NCT00046293 study?
This clinical trial studies the following conditions: Cerebrovascular Accident.
What interventions are being tested in trial NCT00046293?
The interventions under investigation include: Reopro (DRUG), Retrovase (DRUG).
Who is sponsoring clinical trial NCT00046293?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00046293 being conducted?
This trial has 3 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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