Overview

Rivaroxaban Plus ASA in Embolic Stroke of Undetermined Source(AREST-ESUS)

Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
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 acute ischemic stroke treatment in recent decades,consensus treatment of all guidelines is still ASA
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mazandaran University of Medical Sciences
Treatments:
Rivaroxaban
Criteria
Inclusion Criteria:

1. signing the inform consent

2. recent ischemic stroke ( 7-60) days with criteria of ESUS

3. only one risk factors of potential embolic source including:

1. PTFV1 in standard ECG ≥0.05 mm.s or ≥0.005 mv.s

2. LVH in standard ECG( Sokolow index≥ 35 mm) or on echocardiography

3. Moderate or severe valvular disorder on echocardiography (except MS)

4. PFO without indication of occlusion

5. Left atrium enlargement in echocardiography

Exclusion Criteria:

1. History of hypersensitivity to the investigational medicinal product

2. Indication for anticoagulation

3. Indication for dual antiplatelet therapy

4. Contraindication to investigational medications

5. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic
intra-articular bleeding

6. Gastrointestinal bleed or major surgery within 3 months

7. Planned or likely revascularization (any angioplasty or vascular surgery) within the
next 3 months

8. HAS-BLED score >3

9. Severe non-cardiovascular comorbidity with life expectancy < 3 months

10. Severe renal failure, defined as Glomerular Filtration Rate (GFR) <15ml/min, Dialysis,
transplant, Cr >2.26 mg/dL

11. Severe hepatic insufficiency, Cirrhosis or Bilirubin >2x Normal or AST/ALT/AP >3x
Normal

12. Modified Rankin Scale of >=4 at time of randomization or inability to swallow
medications.

13. Hemorrhagic transformation of infarction detected by Brain CT or MRI at the time of
drug application

14. Radiological or microbiological evidence of COVID-19 infection