Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT)

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 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 x10⁹/l) or neutropenia/granulocytopenia (<1 x10⁹/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 or treatment in such a study within the last 7 days.
• Previously enrolled in the POINT study.