Stroke, Prevention
Conditions
Keywords
ESUS, DOACS, Prevention
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 acute ischemic stroke treatment in recent decades,consensus treatment of all guidelines is still ASA
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. Patients with recent stroke with criteria of ESUS, will be randomized to Rivaroxaban 2.5 mg BID plus ASA 80 mg daily or ASA 80 mg plus placebo (1:1 ratio) and have visit every 3 month until 1 year
Interventions
Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily
DRUGRivaroxaban placebo tablets
Placebo tablets add to ASA 80 mg daily that is standard treatment
Sponsors
Mazandaran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of stroke recurrence | Rate of stroke recurrence during one year fallow up | Number of stroke events during 1 year of study |
| Rate of major bleeding | During 1 year of study | Rate of major bleeding according to criteria of the International Society of Thrombosis and Hemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of stroke or systemic embolisms | During 1 year of study | Number of stroke or systemic embolisms recurrence during 1 year of study |
| Mortality rate | During 1year of study | Number of all cause mortality during study |
| Rate of non-major bleeding | During 1year of study | Rate of non-major bleeding according to criteria of the International Society of Thrombosis and Hemostasis |
| Rate of intracranial bleeding | During 1year of study | Rate of ICH during study |
| Rate of fatal bleeding | During 1 year of study | Rate of fatal bleeding in any site |
Countries
Iran
Outcome results
None listed