Aspirin Plus Rivaroxaban Efficacy and Safety in Embolic Stroke of Undetermined Source: A Randomized, Placebo Controlled, Outcome Assessor Blind, Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Rate of stroke recurrence
研究概览
简要总结
Approximately 17% of all patients with stroke are classified as having ESUS, which is associated with a considerable rate of stroke recurrence 4-5 % per year.
Despite recent scientific advances in acute ischemic stroke treatment in recent decades,consensus treatment of all guidelines is still ASA
详细描述
This is an outcome assessor blind, randomized, parallel, placebo-controlled pilot study on ischemic stroke of undetermined source which will be conducted in Bu Ali Sina hospital in Sari, Iran.
Patients with recent stroke with criteria of ESUS, will be randomized to Rivaroxaban 2.5 mg BID plus ASA 80 mg daily or ASA 80 mg plus placebo (1:1 ratio) and have visit every 3 month until 1 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signing the inform consent
- •recent ischemic stroke ( 7-60) days with criteria of ESUS
- •only one risk factors of potential embolic source including:
- •PTFV1 in standard ECG ≥0.05 mm.s or ≥0.005 mv.s
- •LVH in standard ECG( Sokolow index≥ 35 mm) or on echocardiography
- •Moderate or severe valvular disorder on echocardiography (except MS)
- •PFO without indication of occlusion
- •Left atrium enlargement in echocardiography
排除标准
- •History of hypersensitivity to the investigational medicinal product
- •Indication for anticoagulation
- •Indication for dual antiplatelet therapy
- •Contraindication to investigational medications
- •History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
- •Gastrointestinal bleed or major surgery within 3 months
- •Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
- •HAS-BLED score >3
- •Severe non-cardiovascular comorbidity with life expectancy < 3 months
- •Severe renal failure, defined as Glomerular Filtration Rate (GFR) <15ml/min, Dialysis, transplant, Cr >2.26 mg/dL
- •Severe hepatic insufficiency, Cirrhosis or Bilirubin >2x Normal or AST/ALT/AP >3x Normal
- •Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications.
- •Hemorrhagic transformation of infarction detected by Brain CT or MRI at the time of drug application
- •Radiological or microbiological evidence of COVID-19 infection
研究组 & 干预措施
Intervention
Tablet Rivaroxaban 2.5 mg 2 times daily plus ASA 80 mg daily
干预措施: Rivaroxaban 2.5 Mg Oral Tablet (Drug)
Comparator
Tab ASA 80 mg daily plus placebo ( similar to rivaroxaban tablet) 2 times daily
干预措施: Rivaroxaban placebo tablets (Drug)
结局指标
主要结局
Rate of stroke recurrence
时间窗: Rate of stroke recurrence during one year fallow up
Number of stroke events during 1 year of study
Rate of major bleeding
时间窗: During 1 year of study
Rate of major bleeding according to criteria of the International Society of Thrombosis and Hemostasis
次要结局
- Rate of intracranial bleeding(During 1year of study)
- Rate of fatal bleeding(During 1 year of study)
- Mortality rate(During 1year of study)
- Rate of stroke or systemic embolisms(During 1 year of study)
- Rate of non-major bleeding(During 1year of study)
研究者
Athena Sharifi Razavi
Assistant Professor in Neurology
Mazandaran University of Medical Sciences