Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke

Completed · Phase 2

Conditions studied: Ischemic Stroke, Stroke, Brain Infarction

In brief

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 likely to have a better outcome than individuals treated with standard IV rt-PA alone.

Key facts

Study ID

NCT00894803

Run by

University of Cincinnati

People needed

126

Starts

2009-07-01

Expected to finish

2012-12-01

Last updated by the study team

2014-04-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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 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.

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 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.

Where it is running

• UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
• University of California San Diego — San Diego, California, United States
• UCLA Medical Center Santa Monica — Santa Monica, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• St. Elizabeth Healthcare Edgewood — Edgewood, Kentucky, United States
• St. Elizabeth Healthcare Florence — Florence, Kentucky, United States
• St. Elizabeth Healthcare Ft. Thomas — Fort Thomas, Kentucky, United States
• Suburban Hospital — Bethesda, Maryland, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Mission Hospital, Inc. — Asheville, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University Hospital — Cincinnati, Ohio, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• The Jewish Hospital — Cincinnati, Ohio, United States
• Mercy Hospital, Western Hills — Cincinnati, Ohio, United States
• Mercy Hospital Mt Airy — Cincinnati, Ohio, United States
• Bethesda North Hospital — Cincinnati, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• West Virginia University Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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