Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial
1 other identifier
interventional
94
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 stroke
Started Jul 2003
Longer than P75 for phase_1 stroke
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 7, 2005
CompletedFirst Posted
Study publicly available on registry
November 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMay 8, 2009
May 1, 2009
November 7, 2005
May 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage .
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
at 24 hours from symptom onset
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
The Christ Hospital, 2139 Auburn Ave.
Cincinnati, Ohio, 45219, United States
University of Cincinnati, University Hospital, 234 Goodman Ave.
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital, 375 Dixmyth Ave.,
Cincinnati, Ohio, 45220-2489, United States
The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd,
Cincinnati, Ohio, 45236, United States
Mercy Hospital, Western Hills, 3131 Queen City Ave.
Cincinnati, Ohio, 45238, United States
Mercy Hospital, Mt Airy, 2446 Kipling Ave.
Cincinnati, Ohio, 45239, United States
Bethesda North Hospital, 10500 Montgomery Rd
Montgomery, Ohio, 45242, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arthur Pancioli, MD
University of Cincinnati College of Medicine, Department of Emergency Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 7, 2005
First Posted
November 9, 2005
Study Start
July 1, 2003
Study Completion
July 1, 2007
Last Updated
May 8, 2009
Record last verified: 2009-05