Overview

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.