Argatroban TPA Stroke Study [SPOTRIAS] "ARTTS"

Recruiting

Phase N/A Results

Trial Description

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.

Interventions

  • Argatroban (Novastan┬«)Drug
    Intervention Desc: Argatroban is an anticoagulant that is a small molecule direct thrombin inhibitor that is given intravenously and is metabolized in the liver with a half life of about 50 minutes.
  • IV rt-PA Drug
    Other Names: Alteplase, Activase
    Intervention Desc: Thrombolytic

Trial Design

Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Symptomatic and radiographic intracerebral hemorrhage.
Secondary Arterial recanalization.

Sponsors

The University of Texas Health Science Center, Houston