The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

A transient ischemic attack (TIA) is a brief episode of neurological dysfunction that often is a harbinger of disabling strokes.  An ischemic stroke is a cerebral infarction or brain attack.  The primary goal of the POINT trial is to determine if the drug clopidogrel (used to reduce or prevent blood clots) combined with aspirin is effective in preventing ischemic stroke and myocardial infarction (heart attack).

In this 7-year trial, which will recruit 5,840 subjects, participants will be randomized to receive either the study drug clopidogrel combined with aspirin or a placebo combined with aspirin. Individuals over age 18 who can be randomized and begin treatment within 12 hours of the time last known free of new ischemic symptoms will be enrolled. Participants will be followed for 90 days after randomization.

If trial results are positive, treatment with clopidogrel could reduce the burden of stroke in the U.S. and substantially reduce costs of care.

Eligibility Criteria:

Inclusion:

  • Neurological deficit, based on history or exam, attributable to focal brain ischemia and EITHER:
    • High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score  ≥ (greater than or equal to) 4 OR
    • Minor ischemic stroke: residual deficit with NIHSS ≤(less than or equal to) 3 at the time of randomization.
  • Ability to randomize within 12 hours of time last known free of new ischemic symptoms
  • Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor or abscess that could explain symptoms or contraindicate therapy.
  • Ability to tolerate aspirin at a dose of 50-325 mg/day.

Exclusion

  • Age <18 years.
  • Symptoms of TIA limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
  • In the judgment of the treating physician, a candidate for thrombolysis, endarterectomy or endovascular intervention, unless the subject declines both endarterectomy and endovascular intervention at the time of evaluation for eligibility.
  • Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
  • Gastrointestinal bleed or major surgery within 3 months prior to index event.
  • History of nontraumatic intracranial hemorrhage.
  • Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).
  • Qualifying ischemic event induced by angiography or surgery.
  • Severe non-cardiovascular comorbidity with life expectancy <3 months.
  • Contraindication to clopidogrel or aspirin.
  • Known allergy
  • Severe renal (serum creatinine >2 mg/dL or 176.8umol/L) or hepatic insufficiency (prior or concurrent diagnosis, with INR >1.5 or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)
  • Hemostatic disorder or systemic bleeding in the past 3 months
  • Current thrombocytopenia (platelet count <100 x10^9/l) or neutropenia/granulocytopenia (<1 x10^9/l)
  • History of drug-induced hematologic or hepatic abnormalities
  • Anticipated requirement for long-term (>7 days) non-study antiplatelet drugs (e.g., dipyridamole, clopidogrel, ticlopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).
  • Not willing or able to discontinue prohibited concomitant medications.
  • Inability to swallow medications.
  • At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).
  • Unavailability for follow-up.
  • Signed and dated informed consent not obtained from patient.
  • Other neurological conditions that would complicate assessment of outcomes during follow-up.
  • Ongoing treatment in another study of an investigational therapy that may potentially interact with study drug, or treatment in such a study within the last 7 days.
  • Previously enrolled in the POINT study.

Study Design:

Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Study Location:

United States