AHAS1: A pilot trial to determine whether reduced dose intravenous Abciximab achieves optimal platelet inhibition in acute ischemic stroke "AHAS1"

Recruiting

Phase N/A Results N/A

Trial Description

to determine platelet inhibition with our dosing protocol and its relationship to complications and outcomes.

Interventions

  • Abciximab (ReoPro®)Drug
    Intervention Desc: Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor
  • Heparin (acute stroke) Drug
    Intervention Desc: Intravenous anticoagulant.

Patient Involvement

Abciximab treatment protocol: Following informed consent, an IV abciximab bolus dose of 0.2mg/kg (max of 16 mg) and infusion dose of 0.05ug/kg/min over 12 hours (max of 2.9 mg over 12 hours) resulting in a maximal dose ~70% of AbESTT-II. Heparin is administered as a 35U/Kg bolus (max: 2500 U) followed by infusion of 17 U/Kg/hr, dose changes are determined by a computerized algorithm with a treatment duration goal of 36 hours.Platelet Function Testing with Verify Now™: Platelet aggregation units are obtained before treatment and 10-20 minutes after abciximab bolus.

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of patients who achieve good outcome at 3 months in terms of reduction in NIHSS of at least 4 or achieving an mRS of 0-2 will be computed based on platelet inhibition and between group comparisons.
Secondary Secondary analysis will involve platelet inhibition along with baseline NIHSS, age, glucose and time to treatment as independent variables for stepwise regression with good outcome on dichotomized scales (eg: mRS 0-2), hemorrhage and mortality as dependant variables.

Sponsors

Veterans Affairs Medical Center