AbESTT-II
Abciximab in Emergent Stroke Treatment Trial - II
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Status:
Study was permanently stopped in October 2005 due to a high rate of intracranial hemorrhage. Final evalution and follow-up data is expected to be released in 2006.
Purpose:
To evaluate functional outcome in ischemic stroke patients treated with abciximab within 5 hours of stroke, patients treated 5-6 hours after stroke, and patients treated within 3 hours of awakening with stroke symptoms.
Interventions:
Abciximab
Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor
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Year Started:
2003
Design:
Randomized, double-blind, international, multi-center, placebo-controlled trial.
Inclusion Criteria
Patients treatable within 5 hours of stroke onset, patients treatable 5-6 hours after stroke onset, or patients treatable within 3 hours of awakening with stroke symptoms.
Patient Involvement:
Patients will be randomized to receive either abciximab or placebo given as a bolus (0.25 mg/kg), followed by 12 hours infusion (0.125 µg/kg/min, 10µg/min maximum).
Primary Outcome:
Functional outcome measured by the modified Rankin Scale (mRS) responder analysis at 3 months in patients treated within 5 hours of stroke onset. Responders are patients with a baselin NIHSS of 4-7 must achieve an mRS of 0, and those with baseline of NIHSS of 8-14 must achieve = 1. The most severe patients (NIHSS 15-22) must achieve mRS = 2.
Secondary Outcome:
Proportion of patients with neurological recovery (NIHSS 0 - 1) at 3 months and all-causes of mortality during the first 3 months in patients enrolled within 5 hours.
Source of Information:
Presented at the 30th International Stroke Conference (February 2005). Presented at the 13th European Stroke Conference (May 2004).
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Web Links and Publications:
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This information last updated on: 5/14/2008
Reviewed on: 05/14/2008.
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