ReoPro and Retavase to Restore Brain Blood Flow After Stroke

Completed · Phase 2

Conditions studied: Cerebrovascular Accident

In brief

This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after ischemic stroke (stroke resulting from a blood clot in the brain). The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of onset of the stroke and most patients do not get to the hospital early enough to benefit from it. There is thus a pressing need to develop effective stroke treatments that can be initiated more than 3 hours after onset. Patients between 18 and 80 years of age who have experienced 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 physical examination, blood tests and a magnetic resonance imaging (MRI) scan (if an MRI was not done during the stroke evaluation). All participants will receive ReoPro. Some will also receive Retavase, which may boost the effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be monitored with physical examinations, blood tests, computed tomography (CT) scans, and three or four MRI scans of the brain to evaluate both the response to treatment and side effects of the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study medication, and possibly during screening for this study. CT involves the use of specialized x-rays to obtain images of the brain. The patient lies still in the scanner for a short time while the X-ray images are formed. MRI uses a strong magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a medicine called gadolinium contrast is injected in a vein. This medicine brightens the images, creating better pictures of the blood flow.

Key facts

Study ID

NCT00039832

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

42

Starts

2002-03-01

Expected to finish

2008-05-01

Last updated by the study team

2011-09-21

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 impossible to determine with high degree of confidence.
• Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI 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 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
• Contraindication to MRI scan.
• 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 or MRI.
• Evidence of microbleed on gradient echo MRI (GRE).
• CT or MRI evidence of non-vascular cause for the neurological symptoms.
• Signs of mass effect causing shift of midline structures.
• Incomplete or uninterpretable DWI and PWI.
• DWI abnormality larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment.
• Satellite DWI hyperintensity with corresponding hyperintensity on T2 weighted image or FLAIR in a vascular territory different than the index stroke (this is evidence of a new ischemic lesion possibly greater than 24 hours in duration).
• 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.

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Suburban Hospital — Bethesda, Maryland, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Ruprecht Karl Heidelberg Hospital — Heidelberg, Germany

Full record on ClinicalTrials.gov

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