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

Recruiting

Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Neurological deficit (based on history or exam) attributed to focal brain ischemia and EITHER:
- High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score of (greater than or equal to) 4 OR
- Minor ischemic stroke: residual deficit with NIHSS of (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 does of 50-325 mg/day.
Exclusion Criteria
- Age <18 years
- TIA symptoms 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 International Normalized Ratio (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 (<1 x10^9/l)
- History of drug-induced hematologic or hepatic abnormalities
- Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).
- 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 that may potentially interact with study drug, or treatment in such a study within the last 7 days.
- Previously enrolled in the POINT study.