Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a full dose of IV recombinant tissue plasminogen activator (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.

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

Details

• Lead Sponsor: Arthur Pancioli
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Eptifibatide

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 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 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 International Normalized Ratio (INR) > 1.7.

• 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.

• Subjects who received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) as deep vein thrombosis (DVT) prophylaxis or in full dose within the previous 24 hours.

• Subjects who received heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, or lepirudin) within 48 hours from screening must have had a normal partial prothrombin time (PTT).

• Subjects who received Factor Xa inhibitors (such as fondaparinux) or direct thrombin inhibitors (such as dabigatran) within the last 4 days.

• 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.