- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00250991
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd
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California
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Los Angeles, California, United States, 90024
- University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave.
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Santa Monica, California, United States, 90404
- Santa Monica-UCLA Medical Center, 1250 16th Street
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Santa Monica, California, United States, 90404
- St. John's Health Center, 1328 22nd St
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Kentucky
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Edgewood, Kentucky, United States, 41017
- St. Elizabeth Medical Center South, One Medical Village Drive
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Louisville, Kentucky, United States, 40202
- Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way
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Michigan
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Ann Arbor, Michigan, United States, 48109-0303
- University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303
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New York
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New Hyde Park, New York, United States, 11040
- Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue
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Ohio
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Cincinnati, Ohio, United States, 45219
- The Christ Hospital, 2139 Auburn Ave.
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati, University Hospital, 234 Goodman Ave.
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Cincinnati, Ohio, United States, 45220-2489
- Good Samaritan Hospital, 375 Dixmyth Ave.,
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Cincinnati, Ohio, United States, 45236
- The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd,
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Cincinnati, Ohio, United States, 45238
- Mercy Hospital, Western Hills, 3131 Queen City Ave.
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Cincinnati, Ohio, United States, 45239
- Mercy Hospital, Mt Airy, 2446 Kipling Ave.
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Montgomery, Ohio, United States, 45242
- Bethesda North Hospital, 10500 Montgomery Rd
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital, 1200 South Cedar Crest Blvd
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Brown University, Rhode Island Hospital, 593 Eddy St.
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University, University Hospital, 1211 22nd Ave. S.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have a serious measurable neurological deficit on the NIH Stroke Scale due to focal brain ischemia.
- An NIH Stroke Scale score >5 at the time that intravenous study drug is begun.
- Age: 18 through 80 years (i.e. candidates must have had their 18th birthday, but not had their 81st birthday).
- Intravenous therapy must be initiated within 3 hours of onset of stroke symptoms.
Exclusion Criteria:
- History of stroke in the past 3 months.
- Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal
- Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mmHg or aggressive measures to lower blood pressure to below these limits are needed.
- Presumed septic embolus
- Presumed pericarditis including pericarditis after acute myocardial infarction
- Recent (within 30 days) surgery or biopsy of parenchymal organ
- Recent (within 30 days) trauma, with internal injuries or ulcerative wounds
- Recent (within 90 days) severe head trauma or head trauma with loss of consciousness
- Any active or recent (within 30 days) serious systemic hemorrhage
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with prothrombin time greater than 15 or INR > 1.4
- Baseline lab values: positive urine pregnancy test, glucose < 50 or > 400 mg/dl, platelets <100,000 /mm3, Hct <25 %, or creatinine > 4 mg/dl
- Ongoing renal dialysis, regardless of creatinine
- If heparin has been administered within 48 hours, the patient must have a normal partial thromboplastin time (PTT)
- Arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days
- Seizure at onset of stroke
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- Other serious, advanced, or terminal illness or any other condition that the investigator feels would pose a significant hazard to the patient if rt-PA or eptifibatide therapy were initiated
- Patients whose peripheral venous access is so poor that they are unable to have two standard peripheral Intravenous lines started.
- Current participation in another research drug treatment protocol. Patient cannot start another experimental agent until after 90 days
- Informed consent is not or cannot be obtained
- Any known history of amyloid angiopathy.
Exclusion Criteria/CT Scan:
- High density lesion consistent with hemorrhage of any degree.
- Significant mass effect with midline shift.
- Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage .
Time Frame: within 36 hours
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within 36 hours
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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
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at 24 hours from symptom onset
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arthur Pancioli, MD, University of Cincinnati College of Medicine, Department of Emergency Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Ischemic Stroke
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Tissue Plasminogen Activator
- Eptifibatide
Other Study ID Numbers
- P50NS044283 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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