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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Argatroban IV Infusion at 1mcg/kg/min for 48 hours.
University of Alabama-Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Tulane University
New Orleans, Louisiana, United States
University of Texas-Southwestern Dallas
Dallas, Texas, United States
Symptomatic and Radiographic Intracerebral Hemorrhage
Significant intracerebral hemorrhage as defined by either: 1. Symptomatic intracerebral hemorrhage or 2. Parenchymal hematoma type 2.
Time frame: Within 7 days of enrollment
Arterial Complete Recanalization at 2 Hours Post tPA Bolus
Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.
Time frame: 2 hours complete recanalization post tPA bolus
Arterial Complete Recanalization at 24 Hours Post tPA Bolus
Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.
Time frame: 24 hours from tPA bolus
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Memorial Hermann Hospital-Medical Center
Houston, Texas, United States
Memorial Hermann Southwest Hospital
Houston, Texas, United States