Status:
COMPLETED
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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)...
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). T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00250991
Start Date
July 1 2003
End Date
July 1 2007
Last Update
May 8 2009
Active Locations (19)
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1
Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd
Phoenix, Arizona, United States, 85013
2
University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave.
Los Angeles, California, United States, 90024
3
Santa Monica-UCLA Medical Center, 1250 16th Street
Santa Monica, California, United States, 90404
4
St. John's Health Center, 1328 22nd St
Santa Monica, California, United States, 90404