Status:
COMPLETED
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Ischemic Stroke
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom onset are more li...
Detailed Description
The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA (recombinant tissue plasminogen activator) in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER Stroke) trial is a Phase II trial and par...
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 the rt-PA is begun.
- Age: 18 through 85 years (i.e. candidates must have had their 18th birthday, but not had their 86th birthday).
- Intravenous rt-PA 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 Iinternational Normalized Ratio (INR) \> 1.7.
- Baseline lab values: positive urine pregnancy test, glucose \< 50 or \> 400 mg/dl, platelets \<100,000 /mm3, Hct (hematocrit) \<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.
- 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 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00894803
Start Date
July 1 2009
End Date
December 1 2012
Last Update
April 17 2014
Active Locations (20)
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1
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90024
2
University of California San Diego
San Diego, California, United States, 92103
3
UCLA Medical Center Santa Monica
Santa Monica, California, United States, 90404
4
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010