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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Eptifibatide; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.