Protocol Number: 02-N-0154

Title:

ReoPro Retavase Reperfusion of Stroke Safety Study - Imaging Evaluation

Number:

02-N-0154

Summary:

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.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Stroke

Abciximab

Reteplase

MRI

Cerebral Blood Flow

Recruitment Keyword(s):

None

Condition(s):

Cerebrovascular Accident

Investigational Drug(s):

ReoPro and Retavase

Investigational Device(s):

None

Interventions:

Drug: ReoPro and Retavase

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

[No authors listed] Tissue plasminogen activator for acute ischemic stroke The National Instituteof Neurological Disorders and Stroke rt-PA Stroke Study Group N Engl J Med 1995 Dec 14;333(24):1581-7

Furlan A, Intra-arterial prourokinase for acute ischemic stroke The PROACT II study: arandomized controlled trial Prolyse in Acute Cerebral Thromboembolism JAMA 1999 Dec 1;282(21):2003-11

Hacke W, Randomised double-blind placebo-controlled trial of thrombolytic therapy withintravenous alteplase in acute ischaemic stroke (ECASS II) SecondEuropean-Australasian Acute Stroke Study Investigators Lancet 1998 Oct 17;352(9136):1245-51

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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