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

Mazandaran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prevention; Stroke

Treatments: Drug: Rivaroxaban placebo tablets; Drug: Rivaroxaban 2.5 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04273516

3498

Details and patient eligibility

About

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

Full 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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Tablet Rivaroxaban 2.5 mg 2 times daily plus ASA 80 mg daily

Treatment:

Drug: Rivaroxaban 2.5 Mg Oral Tablet

Comparator

Placebo Comparator group

Description:

Tab ASA 80 mg daily plus placebo ( similar to rivaroxaban tablet) 2 times daily

Treatment:

Drug: Rivaroxaban placebo tablets