Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial

Completed · Phase 1/Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00250991

Run by

University of Cincinnati

People needed

94

Starts

2003-07-01

Expected to finish

2007-07-01

Last updated by the study team

2009-05-08

Who can join

Age: 18 and older, up to 80. 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 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
• 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.

Where it is running

• Barrow Neurologic Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Rd — Phoenix, Arizona, United States
• University of California, Los Angeles, UCLA Medical Center, 10833 Le Conte Ave. — Los Angeles, California, United States
• Santa Monica-UCLA Medical Center, 1250 16th Street — Santa Monica, California, United States
• St. John's Health Center, 1328 22nd St — Santa Monica, California, United States
• St. Elizabeth Medical Center South, One Medical Village Drive — Edgewood, Kentucky, United States
• Jewish Hospital Louisville, Jewish Hospital Healthcare Services Inc., 200 Abraham Flexner Way — Louisville, Kentucky, United States
• University of Michigan, University of Michigan Health System, 1500 E. Medical Center Drive, TC B1354, Box 0303 — Ann Arbor, Michigan, United States
• Long Island Jewish, North Shore-Long Island Jewish Health System, 270-05 76 Avenue — New Hyde Park, New York, United States
• The Christ Hospital, 2139 Auburn Ave. — Cincinnati, Ohio, United States
• University of Cincinnati, University Hospital, 234 Goodman Ave. — Cincinnati, Ohio, United States
• Good Samaritan Hospital, 375 Dixmyth Ave., — Cincinnati, Ohio, United States
• The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd, — Cincinnati, Ohio, United States
• Mercy Hospital, Western Hills, 3131 Queen City Ave. — Cincinnati, Ohio, United States
• Mercy Hospital, Mt Airy, 2446 Kipling Ave. — Cincinnati, Ohio, United States
• Bethesda North Hospital, 10500 Montgomery Rd — Montgomery, Ohio, United States
• Lehigh Valley Hospital, 1200 South Cedar Crest Blvd — Allentown, Pennsylvania, United States
• University of Pennsylvania, University of Pennsylvania Medical Center, 3400 Spruce Street — Philadelphia, Pennsylvania, United States
• Brown University, Rhode Island Hospital, 593 Eddy St. — Providence, Rhode Island, United States
• Vanderbilt University, University Hospital, 1211 22nd Ave. S. — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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