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| Sponsored by: |
The University of Texas Health Science Center, Houston |
| Information provided by: | The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00268762 |
Purpose
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 |
| ChemIDplus related topics: | Alteplase Tissue-type plasminogen activator Argatroban |
| 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.
Eligibility
| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |||||
| The University of Texas Health Science Center, Houston |
| Principal Investigator: | James C, Grotta, MD | The University of Texas Health Science Center, Houston |
More Information
Introduction of the staff and facility of the stroke team, explanation of stroke, types of strokes, treatment, risk factors, recovery, clinical trials, and contact information. 
  |
| Responsible Party: | University of Texas-Houston Department of Neurology ( James C. Grotta, MD ) |
| Study ID Numbers: | ARGATROBAN TPA STROKE STUDY, P50NS44227 project #2 |
| First Received: | December 20, 2005 |
| Last Updated: | June 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00268762 |
| Health Authority: | United States: Food and Drug Administration |
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