KCT0008900尚未招募Unknown
Exploratory comparison of clopidogrel-based antiplatelet therapy versus warfarin as secondary prevention strategy for antiphospholipid syndrome-related stroke
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Adults aged =19 years
- •2) Patients who have received treatment for ischemic stroke (cerebral infarction, central retinal artery occlusion, branch retinal artery occlusion) or *transient ischemic attack at one of the trial centers.
- •*Transient ischemic attack
- •In cases where sudden focal neurological symptoms that completely improves within 24 hours, which are presumed to be caused by ischemic causes of cerebral vessels or retinal artery. A neurologist must confirm the diagnosis based on clinical and neuroimaging evaluation.
- •3) Patients satisfying the laboratory criteria* for APS
- •A. Patients who can be diagnosed with antiphospholipid antibody syndrome as the test performed at each trial center satisfies the laboratory diagnostic criteria for antiphospholipid antibody syndrome, can be included in the study irrespective of central laboratory test results.
- •B. Before trial registration (e.g.: Only one positive test for antiphospholipid antibodies, with no more than a 12-week interval between tests). These patients can be included only if they satisfy the laboratory diagnostic criteria in test results from the central laboratory.
- •*Laboratory diagnostic criteria for APS (2006 Sydney criteria): Satisfies at least one of items 1–3
- •1. At least 2 positive tests for lupus anticoagulant (LA) with an interval of at least 12 weeks
- •2. Anti-cardiolipin antibody (aCL) IgG or IgM detected at a medium/high titer (>40 IgG/IgM phospholipid units (GPL/MPL) or >99th percentile of the healthy control group) at least twice with an interval of at least 12 weeks
- •3. Anti-ß2 glycoprotein I antibody (aß2GPI) IgG or IgM detected at a medium/high titer (>40 IgG/IgM phospholipid units (GPL/MPL) or >99th percentile of the healthy control group) at least twice with an interval of at least 12 weeks
- •4) Patients (or their legal proxy) who voluntarily provide written consent after receiving an explanation of the study
排除标准
- •1) Patients with APS at high risk of thrombotic events
- •A. Those who are positive for all 3 types of aPL
- •B. Those who exhibit a continually high titer (=80 U/mL) of aCL or aß2GPI
- •2) Patients with systemic lupus erythematosus
- •3) Patients who cannot discontinue their current anticoagulant/antiplatelet medication: those with a history of atrial fibrillation, valvular heart disease, percutaneous coronary intervention, etc.
- •4) Patients who are pregnant or breastfeeding, or who are expecting to become pregnant during the study period
- •5) Patients who are ineligible to continue participating in the trial for at least 2 years, based on the appraisal of at least one investigator
研究者
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