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

Last updated: October 18, 2023
Sponsor: Mazandaran University of Medical Sciences
Overall Status: Completed

Phase

2/3

Condition

Stroke

Cerebral Ischemia

Treatment

Rivaroxaban placebo tablets

Rivaroxaban 2.5 Mg Oral Tablet

Clinical Study ID

NCT04273516
3498
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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:
  4. PTFV1 in standard ECG ≥0.05 mm.s or ≥0.005 mv.s
  5. LVH in standard ECG( Sokolow index≥ 35 mm) or on echocardiography
  6. Moderate or severe valvular disorder on echocardiography (except MS)
  7. PFO without indication of occlusion
  8. Left atrium enlargement in echocardiography

Exclusion

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 atraumaticintra-articular bleeding
  6. Gastrointestinal bleed or major surgery within 3 months
  7. Planned or likely revascularization (any angioplasty or vascular surgery) within thenext 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 >3xNormal
  12. Modified Rankin Scale of >=4 at time of randomization or inability to swallowmedications.
  13. Hemorrhagic transformation of infarction detected by Brain CT or MRI at the time ofdrug application
  14. Radiological or microbiological evidence of COVID-19 infection

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Rivaroxaban placebo tablets
Phase: 2/3
Study Start date:
August 22, 2020
Estimated Completion Date:
April 30, 2023

Study 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

Connect with a study center

  • Bou- Ali Sina Hospital

    Sari, Mazandaran
    Iran, Islamic Republic of

    Site Not Available

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