Abciximab and rt-PA in Acute Ischemic Stroke Treatment
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Status:
Trial complete. Results published in December of 2004.
Purpose:
To evaluate the safety and potential benefits and abciximab administered in conjunction with half-dose rt-PA in acute ischemic stroke patients.
Interventions:
Abciximab
Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor
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Tissue plasminogen activator
Thrombolytic
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Year Started:
2002
Year Presented:
2003
Design:
Single-center, open-label, phase I, safety and efficacy study.
Inclusion Criteria
Acute ischemic stroke within three hours, NIHSS greater than 5, absence of hemorrhage as verified by CT.
Exclusion Criteria
NIHSS less than 5 or greater than 20, previous stoke within three months, pre-exisiting neurological deficit, seizures, indication of hemorrhage, aneurysm, avm, or neoplasm.
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).
Primary Outcome:
Frequency of symptomatic intracerebral hemorrhage at 24 hours.
Secondary Outcome:
NIHSS at discharge.
Results:
Of the five patients in the study, one (20%) experienced an intracerebral hemorrhage. The median change in NIHSS score at hospital discharge was a reduction of 6 points (p=0.07).
Source of Information:
Presented at the 28th International Stroke Conference (February 2003). Acad Emerg Med. 2003 Dec;10(12):1396-9.
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Web Links and Publications:
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This information last updated on: 7/16/2008
Reviewed on: 07/16/2008.
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