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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00268762 |
Is the combination of low doses of argatroban in combination with rt-PA safe, and does it increase recanalization in patients with acute ischemic stroke.
Condition | Intervention | Phase |
---|---|---|
Acute Ischemic Stroke |
Drug: argatroban |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study To Determine The Safety Of Argatroban Injection In Combination With rt-PA In Patients With Acute Ischemic Stroke |
Estimated Enrollment: | 65 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
All patients with acute ischemic stroke who qualify for IV rt-PA under accepted guidelines, and who have an occluded middle cerebral artery documented on TCD, receive standard dose IV rt-PA and a bolus and 48 hour infusion of argatroban aimed at prolonging the aPTT 1/75 X control. Follow up CT scanning and TCD every 30 minutes for 2 hours and then daily will determine the incidence of hemorrhage, recanalization and reocclusion, and serial neurological exam will determine the clinical outcome.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James C, Grotta, MD | 713-500-7088 | james.c.grotta@uth.tmc.edu |
Contact: Mary Jane Hess, RN/BSN | 713-500-7078 | mary.jane.hess@uth.tmc.edu |
United States, Texas | |
Memorial Hermann Hospital-Medical Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: James C. Grotta, MD 713-500-7088 james.c.grotta@uth.tmc.edu |
Principal Investigator: | James C, Grotta, MD | The University of Texas Health Science Center, Houston |
Responsible Party: | University of Texas-Houston Department of Neurology ( James C. Grotta, MD ) |
Study ID Numbers: | ARGATROBAN TPA STROKE STUDY, P50NS44227 project #2 |
Study First Received: | December 20, 2005 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00268762 |
Health Authority: | United States: Food and Drug Administration |
stroke thrombin inhibition thrombolysis bleeding outcome |
Thrombin Cerebral Infarction Stroke Vascular Diseases Tissue Plasminogen Activator Central Nervous System Diseases Ischemia |
Hemorrhage Brain Diseases Cerebrovascular Disorders Argatroban Brain Ischemia Brain Infarction Infarction |
Anticoagulants Therapeutic Uses Hematologic Agents Nervous System Diseases |
Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |