Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)
Condition: Stroke; Brain Infarction
MeSH terms: Stroke; Ischemic Stroke; Brain Infarction; Infarction
Intervention: Eptifibatide
Intervention description: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
Intervention MeSH terms: Eptifibatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: acute ischemic stroke; stroke; rt-PA, thrombolytic; t-PA; recombinant tissue plasminogen activator; Activase; eptifibatide; Integrilin; fibrinolytic agents; clot dissolving; blood clot

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.
    

Eligibility 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.