Argatroban Stroke Treatment - A Pilot Safety Study

Completed

Phase 1/2 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.

Detailed Description

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.

Conditions

Interventions

  • Tissue plasminogen activator (Activase┬«)Drug
    Other Names: Alteplase; tPA
    Intervention Desc: Thrombolytic
  • Argatroban (Novastan┬«)Drug
    Intervention Desc: Argatroban IV Infusion at 1mcg/kg/min for 48 hours.
    ARM 1: Kind: Experimental
    Label: Intervention
    Description: Argatroban IV Infusion 1 mcg/kg/min for 48 hours

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

All patients received the standard rtPA dose of 0.9 mg/kg, with 10% of the total dose given in 1 minute and the remainder infused across 60 minutes. Argatroban was administered intravenously within 1 hour of standard rtPA treatment initiation as an initial 100-?g/kg bolus in 3 to 5 minutes, followed by a continuous infusion of 1.0 ?g/kg per minute for 48 hours adjusted to a target partial thromboplastin time (aPTT) of 1.75 times that of the control group (baseline (±10%).

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of intracerebral hemorrhage.
Secondary Complete recanalization at 2 hours.
Primary Symptomatic and radiographic intracerebral hemorrhage Within 7 days of enrollment Yes
Secondary arterial recanalization Within 48 hours of treatment No
Secondary Arterial Complete Recanalization at 2 Hours Post tPA Bolus 2 hours complete recanalization post tPA bolus No
Secondary Arterial Complete Recanalization at 24 Hours Post tPA Bolus 24 hours from tPA bolus No

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