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.
The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage .The primary measure of early beneficial drug activity will be the incidence of early neurological improvement, as measured by the NIHSSS
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd, Phoenix, Arizona 85013, United States
University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave., Los Angeles, California 90024, United States
Santa Monica-UCLA Medical Center, 1250 16th Street, Santa Monica, California 90404, United States
St. John's Health Center, 1328 22nd St, Santa Monica, California 90404, United States
St. Elizabeth Medical Center South, One Medical Village Drive, Edgewood, Kentucky 41017, United States
Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way, Louisville, Kentucky 40202, United States
University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303, Ann Arbor, Michigan 48109-0303, United States
Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue, New Hyde Park, New York 11040, United States
University of Cincinnati, University Hospital, 234 Goodman Ave., Cincinnati, Ohio 45219, United States
The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd,, Cincinnati, Ohio 45236, United States
Good Samaritan Hospital, 375 Dixmyth Ave.,, Cincinnati, Ohio 45220-2489, United States
Bethesda North Hospital, 10500 Montgomery Rd, Montgomery, Ohio 45242, United States
The Christ Hospital, 2139 Auburn Ave., Cincinnati, Ohio 45219, United States
Mercy Hospital, Mt Airy, 2446 Kipling Ave., Cincinnati, Ohio 45239, United States
Mercy Hospital, Western Hills, 3131 Queen City Ave., Cincinnati, Ohio 45238, United States
Lehigh Valley Hospital, 1200 South Cedar Crest Blvd, Allentown, Pennsylvania 18103, United States
University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street, Philadelphia, Pennsylvania 19104, United States
Brown University, Rhode Island Hospital, 593 Eddy St., Providence, Rhode Island 02903, United States
Vanderbilt University, University Hospital, 1211 22nd Ave. S., Nashville, Tennessee 37232, United States
Additional Information
Starting date: July 2003
Ending date: July 2007
Last updated: December 10, 2007
