Platelet-Oriented Inhbition in New transient ischemic attack and minor stroke

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5840

Inclusion Criteria

?Neurologic deficit (based on history or examination) attributed to focal brain ischemia and EITHER:
oHigh risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score >4
Or
oMinor ischemic stroke: residual deficit with NIHSS <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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

?Age <18 years.
?TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
?In the judgement 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)
?Haemostatic 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 haematologic or hepatic abnormalities
?Anticipated requirement for long-term (>7 day) 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 post menopausal 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.