POINT
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT)Trial, a Randomized, Double-blind, Multicenter Clinical Trial
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Status:
This study is ongoing, but not recruiting participants.
Purpose:
To determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day (with a dose of 162 mg daily for 5 days followed by 81 mg daily strongly recommended).
Interventions:
Clopidogrel
Antiplatelet agent
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Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
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Year Started:
2009
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study.
Inclusion Criteria
Neurologic deficit (exam finding or symptom unconfirmable on exam) attributed to focal brain ischemia, with complete resolution of the deficit within 12 hours of symptom onset;
ability to randomize within 12 hours of symptom onset;
ABCD2 score >3; Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
Exclusion Criteria
Age <18 years TIA with residual symptoms 12 hours after onset; stroke after the index event but before enrollment;
symptoms of TIA limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo; gastrointestinal bleed or major surgery within 3 months;
history of intracranial hemorrhage; known carotid artery stenosis >50% that could be responsible for symptoms;
clear indication for anticoagulation anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state); qualifying TIA induced by angiography or surgery; severe non-cardiovascular comorbidity with life expectancy < 3 months; contraindication to clopidogrel or aspirin(i.e.,known allergy, severe renal or hepatic insufficiency, hemostatic disorder or systemic bleeding, history of hemostatic disorder or systemic bleeding history of thrombocytopenia or neutropenia, history of drug-induced hematologic or hepatic abnormalities, low white blood cell (<2 x109/l) or platelet count [<100 x109/l]); anticipated requirement for long-term nonstudy antiplatelet drugs, or NSAIDs affecting platelet function; inability to swallow medications; at risk for pregnancy: woman <45 y without a negative pregnancy test or not committing to adequate birth control (eg, oral contraceptive or two methods of barrier birth control);
unavailability for follow-up; need for proton-pump inhibitor; inability to provide informed consent; other neurological conditions that would complicate assessment of outcomes during follow-up; women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test; currently receiving an investigational drug.
Patient Involvement:
Patient will be randomized to one of two arms: a) Patients assigned to clopidogrel (Loading dose of 600mg followed by 75 milligrams,oral, one tablet daily for 90 days) in addition to aspirin or b) Patients assigned to placebo (loading dose of 8 tablets followed by one tablet daily for 90 days)in addition to aspirin. Patients will have baseline Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy. Patients are then followed for 90 days to observe for major ischemic vascular events.
Primary Outcome:
New ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death.
Secondary Outcome:
Secondary outcomes will be evaluated, separately including risk of ischemic stroke, intracranial hemorrhage, and major hemorrhage, and the composite of the primary outcome and major hemorrhage.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 5/25/2010
Reviewed on: 05/25/2010.
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