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IRCT20200112046094N1 IRCT 2020-08-14 Mazandaran University of Medical Sciences Rivaroxaban in Embolic Stroke of Undetermined Source(ESUS) Aspirin plus Rivaroxaban Efficacy and Safety in Embolic Stroke of Undetermined Source: A Randomized, Placebo Controlled, Outcome Assessor Blind, Clinical Trial 2020-08-22 anticipated 40 Complete https://irct.ir/trial/49627 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomized in a 1:1 fashion to intervention or comparator group. A list of random numbers generated then by using a block randomization method with 4 block size, anonymized patient list encoded. The codes are written on an envelope and the group type (intervention or comparison) is placed on paper inside the envelope. These envelopes are stacked in order. At the time of enrollment of each patient who met the inclusion and exclusion criteria, the upper envelope is removed, and based on the code inside it, it is determined which group it belongs to, Blinding description: Patient list concealed by statistics. Neurologist give drugs or placebo according to randomized code, neurology resident who assess patients outcome so is blind. 3 Ischemic Stroke. Intervention 1: Intervention group: ASA ( entric coated tablet) 80 mg once daily plus Rivaroxaban (film coated tablet)2.5 mg BID for 1 year. Intervention 2: Control group: ASA ( enteric-coated tablet) 80 mg once daily plus placebo BID for 1 year. Placebo will be made in mazandarn university pharmacy school , similar to rivaroxaban. Yes - There is a plan to make this available What will be shared: all unrecognizable data would be sharing When: 6 month after result pblication To whom: Data will be available for researchers and scientific persons. Conditions: If there is a similar published or documented proposal Where to obtain: via email adders athena.sharifi@yahoo.com How to obtain: after request and review the proposal .It takes about 1 month. Comments:
public Fatemeh Ramezanpour
Bou-Ali Sina Hospital,Pasdaran Blvd,Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3014 fatemeh_ramzanpour@yahoo.com Mazandaran University of Medical Sciences scientific Athena Sharifi-Razavi
Bou-Ali Sina Hospital, Pasdaran Blvd, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3014 athena.sharifi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 I63 Cerebral infarction Treatment - Drugs Placebo Intervention group: ASA ( entric coated tablet) 80 mg once daily plus Rivaroxaban (film coated tablet)2.5 mg BID for 1 year Control group: ASA ( enteric-coated tablet) 80 mg once daily plus placebo BID for 1 year. Placebo will be made in mazandarn university pharmacy school , similar to rivaroxaban. 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. 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. NCT04273516 clinicaltrial.gov Mazandaran University of Medical Sciences Approved 2020-07-08 Ethics committee of Mazandaran University of Medical Sciences Bou-Ali Sina Hospital, Pasdaran Blvd, Sari Sari Mazandaran Iran (Islamic Republic of)