Abciximab (ReoPro) in Acute Ischemic Stroke "ReoPro"

Completed

Phase 2 Results

Trial Description

Interventions

  • Abciximab (ReoPro┬«)Drug
    Intervention Desc: Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor

Trial Design

Phase II, randomized, double-blind dose-escalation study of 74 patients at 38 centers.

Patient Involvement

3:1 randomization to one of four escalating doses of abciximab or placebo. Patients were treated with placebo or one of the following four doses of abciximab: 0.15 milligram/kilogram (mg/kg) single bolus of abciximab; 0.20 mg/kg single bolus; 0.20 mg/kg bolus plus 0.125 microgram/kg (mcg/kg) per minute infusion; or 0.25 mg/kg bolus and 0.125 mcg/kg/minute infusion.

Outcomes

Type Measure Time Frame Safety Issue
Primary Day 5 incidence of major intracranial hemorrhage. Follow-up for 3 months.
Secondary Asymptomatic ICH, thrombocytopenia, systemic hemorrhage, stroke progression, stroke recurrence, functional outcome, and all intracranial bleeds at 3 months. Substudies: diffusion/perfusion MRI, MRA, soluble P-selectin.

Sponsors

Lilly Research Laboratories, Indianapolis, IN; Centocor Inc., Malvern, PA