Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial
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|ClinicalTrials.gov Identifier: NCT00250991|
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : May 8, 2009
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: activase Drug: integrilin||Phase 1 Phase 2|
The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) trial is part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care and train acute stroke translational researchers.
Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can affect a person's ability to walk, talk, and function independently. In order to reduce the risk of permanent damage, it is important to restore blood flow to the brain as quickly as possible.
The CLEAR Stroke study will enroll 100 participants with acute stroke due to a blood clot. The purpose of this multi-center, randomized, double-blind study is to determine the effects of using a combination of two drugs, integrilin (or eptifibatide) and activase (or recombinant tissue plasminogen activator, rt-PA, recombinant t-PA), to dissolve blood clots. More specifically, the CLEAR study is being done to determine if a lower dose of activase, given in combination with a second drug, integrilin, is a safe treatment for acute stroke.
Activase, used alone, is already approved by the Food and Drug Administration (FDA) as treatment for patients with a stroke caused by blockage of an artery in the brain and when given within 3 hours of the onset of stroke symptoms. Integrilin is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of integrilin for a stroke victim in combination with activase.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Official Title:||Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial|
|Study Start Date :||July 2003|
|Actual Study Completion Date :||July 2007|
- The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage . [ Time Frame: within 36 hours ]
- The primary measure of early beneficial drug activity will be the incidence of early neurological improvement, as measured by the NIHSSS </= 2 [ Time Frame: at 24 hours from symptom onset ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250991
|Principal Investigator:||Arthur Pancioli, MD||University of Cincinnati College of Medicine, Department of Emergency Medicine|