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Sponsors and Collaborators: |
University of Cincinnati National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00250991 |
The purpose of this study is determine the effects of using of a combination of two drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.
Condition | Intervention | Phase |
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Stroke |
Drug: activase Drug: integrilin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind |
Official Title: | Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial |
Enrollment: | 94 |
Study Start Date: | July 2003 |
Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria/CT Scan:
Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment.
United States, Arizona | |
Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave. | |
Los Angeles, California, United States, 90024 | |
Santa Monica-UCLA Medical Center, 1250 16th Street | |
Santa Monica, California, United States, 90404 | |
St. John's Health Center, 1328 22nd St | |
Santa Monica, California, United States, 90404 | |
United States, Kentucky | |
St. Elizabeth Medical Center South, One Medical Village Drive | |
Edgewood, Kentucky, United States, 41017 | |
Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way | |
Louisville, Kentucky, United States, 40202 | |
United States, Michigan | |
University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303 | |
Ann Arbor, Michigan, United States, 48109-0303 | |
United States, New York | |
Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue | |
New Hyde Park, New York, United States, 11040 | |
United States, Ohio | |
University of Cincinnati, University Hospital, 234 Goodman Ave. | |
Cincinnati, Ohio, United States, 45219 | |
The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd, | |
Cincinnati, Ohio, United States, 45236 | |
Good Samaritan Hospital, 375 Dixmyth Ave., | |
Cincinnati, Ohio, United States, 45220-2489 | |
Bethesda North Hospital, 10500 Montgomery Rd | |
Montgomery, Ohio, United States, 45242 | |
The Christ Hospital, 2139 Auburn Ave. | |
Cincinnati, Ohio, United States, 45219 | |
Mercy Hospital, Mt Airy, 2446 Kipling Ave. | |
Cincinnati, Ohio, United States, 45239 | |
Mercy Hospital, Western Hills, 3131 Queen City Ave. | |
Cincinnati, Ohio, United States, 45238 | |
United States, Pennsylvania | |
Lehigh Valley Hospital, 1200 South Cedar Crest Blvd | |
Allentown, Pennsylvania, United States, 18103 | |
University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Brown University, Rhode Island Hospital, 593 Eddy St. | |
Providence, Rhode Island, United States, 02903 | |
United States, Tennessee | |
Vanderbilt University, University Hospital, 1211 22nd Ave. S. | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Arthur Pancioli, MD | University of Cincinnati College of Medicine, Department of Emergency Medicine |
Responsible Party: | University of Cincinnati College of Medicine, Department of Emergency Medicine ( Arthur Pancioli, MD ) |
Study ID Numbers: | P50NS044283 |
Study First Received: | November 7, 2005 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00250991 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stroke integrilin eptifibatide activase |
recombinant tissue plasminogen activator rt-PA recombinant t-PA SPOTRIAS |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents Cardiovascular Agents Ischemia Brain Diseases |
Cerebrovascular Disorders Fibrin Modulating Agents Brain Ischemia Platelet Aggregation Inhibitors Brain Infarction Infarction Eptifibatide Plasminogen |
Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents Cardiovascular Agents |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Therapeutic Uses Brain Ischemia Platelet Aggregation Inhibitors Cardiovascular Diseases Brain Infarction Eptifibatide |