ISRCTN73630073已完成4 期
POINT: Platelet Oriented Inhibition in New TIA and Minor Ischemic stroke
niversity of California, San Francisco0 个研究点目标入组 4,881 人开始时间: 2014年2月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,881
研究概览
简要总结
2013 protocol in https://www.ncbi.nlm.nih.gov/pubmed/23879752 (added 24/01/2020) 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/29766750 (added 24/01/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Neurologic deficit (based on history or examination) attributed to focal brain ischemia and EITHER:
- •1. High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score >4
- •Minor ischemic stroke: residual deficit with NIHSS <3 at the time of randomization
- •2. Ability to randomize within 12 hours of time last known free of new ischemic symptoms.
- •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.
- •4. Ability to tolerate aspirin at a dose of 50-325 mg/day.
排除标准
- •1. Age <18 years.
- •2. TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
- •3. 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.
- •4. Receipt of any intravenous or intraarterial thrombolysis within 1 week prior to index event.
- •5. Gastrointestinal bleed or major surgery within 3 months prior to index event.
- •6. History of nontraumatic intracranial hemorrhage.
- •7. 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).
- •8. Qualifying ischemic event induced by angiography or surgery.
- •9. Severe noncardiovascular comorbidity with life expectancy <3 months.
- •10. Contraindication to clopidogrel or aspirin:
- •10.1. Known allergy
- •10.2. 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)
- •10.3. Haemostatic disorder or systemic bleeding in the past 3 months
- •10.4. Current thrombocytopenia (platelet count <100 x109/l) or neutropenia/granulocytopenia (<1 x109/l)
- •10.5. History of drug induced haematologic or hepatic abnormalities
- •11. Anticipated requirement for long term (>7 day) nonstudy antiplatelet drugs (e.g., dipyridamole, clopidogrel,
- •iclopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).
- •12. Not willing or able to discontinue prohibited concomitant medications.
- •13. Inability to swallow medications.
- •14. 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).
- •15. Unavailability for followup.
- •16. Signed and dated informed consent not obtained from patient.
- •17. Other neurological conditions that would complicate assessment of outcomes during follow up.
- •18. Ongoing treatment in another study of an investigational therapy, or treatment in such a study within the last 7 days.
- •19. Previously enrolled in the POINT study.
研究者
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