Rationale Intracranial atherosclerotic disease (ICAD) is a pathological process that causes progressive stenosis and cerebral hypoperfusion, leading to stroke occurrence and recurrence around the world. The exact duration of dual antiplatelet therapy (DAPT) for ICAD is unclear in view of long-term risk of bleeding complications. Aim The current study aims to study the efficacy and safety of long-term DAPT (up to 12 months) in patients with ICAD. Sample size Using 80% power and an alpha error of 5 %, presuming a 10%–15% drop-out rate, a total of 2200 patients will be recruited for the study. Methodology This is a prospective, randomised, double-blind, placebo controlled trial. Study outcomes The primary outcomes include recurrent ischaemic stroke (IS) or transient ischaemic attack and any intracranial haemorrhage (ICH), major or minor systemic bleeding at the end of 12 months. Secondary outcomes include composite of any stroke, myocardial infarction or death at the end of 12 months. The safety outcomes include any ICH, major or minor bleeding as defined using GUSTO (Global Use of Streptokinase and tPA for occluded Coronary Arteries) classification at the end of 12 months and 1 month after completion of the drug treatment phase. Discussion The study will provide level I evidence on the duration of DAPT among patients with IS due to ICAD of more than or equal to 50%.

中文翻译：

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狭窄：颅内动脉粥样硬化性疾病引起的缺血性卒中患者的长期单一抗血小板治疗与双重抗血小板治疗——一项随机试验

颅内动脉粥样硬化性疾病（ICAD）是一种导致进行性狭窄和脑灌注不足的病理过程，导致世界各地中风的发生和复发。鉴于出血并发症的长期风险，ICAD 双联抗血小板治疗 (DAPT) 的确切持续时间尚不清楚。目的 本研究旨在研究长期 DAPT（长达 12 个月）对 ICAD 患者的疗效和安全性。样本量 使用 80% 功效和 5% 的 alpha 误差，假设退出率为 10%–15%，总共将招募 2200 名患者参与该研究。方法 这是一项前瞻性、随机、双盲、安慰剂对照试验。研究结果 主要结果包括复发性缺血性中风 (IS) 或短暂性脑缺血发作以及任何颅内出血 (ICH)、12 个月末的严重或轻微全身出血。次要结局包括 12 个月结束时任何中风、心肌梗死或死亡的复合结局。安全性结果包括在药物治疗阶段结束后 12 个月末和 1 个月时使用 GUSTO（全球使用链激酶和 tPA 治疗闭塞冠状动脉）分类定义的任何 ICH、大出血或小出血。讨论 该研究将为 ICAD 超过或等于 50% 的 IS 患者的 DAPT 持续时间提供 I 级证据。