EUCTR2013-001185-41-FI进行中（未招募）1 期
Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, a randomized, double blind, multicentre clinical trial - Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke
niversity of California San Francisco0 个研究点目标入组 5,840 人开始时间: 2014年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,840
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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:
- •oHigh risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score >4
- •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
排除标准
- •?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.
研究者
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