Argatroban Stroke Treatment - A Pilot Safety Study
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study To Determine The Safety Of Argatroban Injection In Combination With Tissue Plasmingen Activator (TPA) In Patients With Acute Ischemic Stroke|
- Symptomatic and Radiographic Intracerebral Hemorrhage [ Time Frame: Within 7 days of enrollment ] [ Designated as safety issue: Yes ]
Significant intracerebral hemorrhage as defined by either:
- Symptomatic intracerebral hemorrhage or
- Parenchymal hematoma type 2.
- Arterial Complete Recanalization at 2 Hours Post tPA Bolus [ Time Frame: 2 hours complete recanalization post tPA bolus ] [ Designated as safety issue: No ]Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.
- Arterial Complete Recanalization at 24 Hours Post tPA Bolus [ Time Frame: 24 hours from tPA bolus ] [ Designated as safety issue: No ]Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.
|Study Start Date:||February 2003|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
Argatroban IV Infusion at 1mcg/kg/min for 48 hours.
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 baseline. 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. For patients without temporal windows, a baseline CT-Angiogram (CTA) demonstrating arterial occlusion can also be enrolled. In those patients, a follow-up CTA (24-36 hours) will be performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268762
|United States, Alabama|
|University of Alabama-Birmingham|
|Birmingham, Alabama, United States, 35249|
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112|
|United States, Texas|
|University of Texas-Southwestern Dallas|
|Dallas, Texas, United States, 75390|
|Memorial Hermann Hospital-Medical Center|
|Houston, Texas, United States, 77030|
|Memorial Hermann Southwest Hospital|
|Houston, Texas, United States, 77074|
|Principal Investigator:||Andrew D. Barreto, MD||The University of Texas Health Science Center, Houston|