Abciximab and rt-PA in Acute Ischemic Stroke Treatment

Completed

Phase N/A Results

Trial Description

To evaluate the safety and potential benefits and abciximab administered in conjunction with half-dose rt-PA in acute ischemic stroke patients.

Interventions

  • Abciximab (ReoPro®)Drug
    Intervention Desc: Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor
  • Tissue plasminogen activator (Activase®)Drug
    Other Names: Alteplase; tPA
    Intervention Desc: Thrombolytic

Trial Design

Single-center, open-label, phase I, safety and efficacy study.

Patient Involvement

Patients with acute ischemic stroke were given a combination therapy of half-dose rt-PA (0.45 mg/kg) and abciximab (initial bolus of 0.25 mg/kg followed by an infusion of 0.125 µg/kg/min for 12 hours).

Outcomes

Type Measure Time Frame Safety Issue
Primary Frequency of symptomatic intracerebral hemorrhage at 24 hours.
Secondary NIHSS at discharge.

Sponsors

National Institute of Neurological Disorders and Stroke - NIH