ReoPro and Retavase to Treat Acute Stroke

Completed · Phase 2

Conditions studied: Cerebrovascular Accident

In brief

This study will determine the dose of Retavase that can safely be combined with ReoPro in treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and Retavase are currently approved by the Food and Drug Administration to treat heart problems caused by blockage of heart arteries. The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is effective only if begun within 3 hours of onset of the stroke, however, and most patients do not get to the hospital early enough to benefit from it. Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to obtain images of the brain. The patient lies on a table that is moved into a cylindrical machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes. All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is infused into the vein over 12 hours. Some patients will also receive one of four doses of Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel. Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments will include physical examinations, blood tests to examine factors involved in blood clotting, and CT scans to evaluate both the response to treatment and drug side effects. They will return for a follow-up examination and CT scan 30 days after treatment. ...

Key facts

Study ID

NCT00046293

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

72

Starts

2002-09-24

Expected to finish

2007-07-20

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients will be excluded from the study for any of the following reasons:
• General
• Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial.
• Time interval since stroke onset of less than 24 hours is impossible to determine with high degree of confidence.
• Symptoms suggestive of subarachnoid hemorrhage, even if CT scan is negative for hemorrhage.
• Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia 2) EKG findings of ST elevation of more greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion 3) Elevated troponin I
• Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
• Patients who would refuse blood transfusions if medically indicated
• Stroke Related
• Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2).
• High clinical suspicion of septic embolus.
• Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
• Baseline NIHSS greater than 16.
• MRI/CT Related
• Evidence of acute or chronic ICH by head CT.
• CT evidence of non-vascular cause for the neurological symptoms.
• Signs of mass effect causing shift of midline structures.
• Patient excluded from the ROSIE protocol by MRI findings.
• Acute ischemic changes on CT larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment.
• Safety Related
• Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control.
• Anticipated need for major surgery within 72 hours after start of study drugs, e.g., carotid endarterectomy, hip fracture repair.
• Any intracranial surgery, serious head trauma (any head injury that required hospitalization), or stroke within the past 3 months.
• Stroke within the past 3 months.
• History of ICH at any time in the past.

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Suburban Hospital — Bethesda, Maryland, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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