Status:
COMPLETED
Rivaroxaban Plus ASA in Embolic Stroke of Undetermined Source(AREST-ESUS)
Lead Sponsor:
Mazandaran University of Medical Sciences
Conditions:
Stroke
Prevention
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ac...
Detailed Description
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. Patien...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04273516
Start Date
August 22 2020
End Date
April 30 2023
Last Update
October 19 2023
Active Locations (1)
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1
Bou- Ali Sina Hospital
Sari, Mazandaran, Iran