Rivaroxaban in Embolic Stroke of Undetermined Source(ESUS)

Phase 3

Recruiting

• Conditions: Ischemic Stroke.; Cerebral infarction

• Registration Number: IRCT20200112046094N1
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of stroke or systemic embolism recur. Timepoint: 12 months after drug administration. Method of measurement: recording in case report form.;Major bleeding events. Timepoint: 12 month after drug administration. Method of measurement: recording in case report form based on International Society on Thrombosis and Haemostasis bleeding scale.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality rate. Timepoint: at the end of 1 year. Method of measurement: recording in case report form.;Non-major bleeding. Timepoint: at the end of 1 year. Method of measurement: recording in case report form.;Fatal bleeding. Timepoint: at the end of 1 year. Method of measurement: record in case study form.