Aspirin plus Rivaroxaban Efficacy and Safety in Embolic Stroke of Undetermined Source: A Randomized, Placebo Controlled, Outcome Assessor Blind, Clinical Trial

Mazandaran University of Medical Sciences0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年8月30日

研究概览

暂无简介。

•Signing the informed consent
•Recent ischemic stroke, with criteria of ESUS defined as:Stroke detected by CT or MRI that is not lacunar,Absence of extracranial or intracranial atherosclerosis causing =50% luminal stenosis in arteries supplying the area of ischemia, No major-risk cardioembolic source of embolism, No other specific cause of stroke identified
•only one risk factor 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), Moderate or severe MR, AR or AS in echocardiography , LVH in echocardiography, left atrium hypertrophy in echocardiography, PFO not candidate for closure

•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 bleeding 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
•Inability to swallow medications
•Hemorrhagic transformation of infarction

发起方