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

NCT04273516 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 3498
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Prevention

Keywords

ESUS; DOACS; Prevention

Outcome Measures

Primary Outcomes (2)

• Rate of stroke recurrence

  Number of stroke events during 1 year of study

  Rate of stroke recurrence during one year fallow up

• Rate of major bleeding

  Rate of major bleeding according to criteria of the International Society of Thrombosis and Hemostasis

  During 1 year of study

Secondary Outcomes (5)

• Rate of stroke or systemic embolisms

  During 1 year of study

• Mortality rate

  During 1year of study

• Rate of non-major bleeding

  During 1year of study

• Rate of intracranial bleeding

  During 1year of study

• Rate of fatal bleeding

  During 1 year of study

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Rivaroxaban 2.5 Mg Oral Tablet

Comparator

PLACEBO COMPARATOR

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

Drug: Rivaroxaban placebo tablets

Interventions

Rivaroxaban 2.5 Mg Oral Tablet DRUG

Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily

Also known as: Axabin 2.5

Intervention

Rivaroxaban placebo tablets DRUG

Placebo tablets add to ASA 80 mg daily that is standard treatment

Also known as: Placebo

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Bou- Ali Sina Hospital

Sari, Mazandaran, Iran

Location

MeSH Terms

Conditions

Stroke

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Athena Sharifi-Razvi

  mazandaran university of medical science

  PRINCIPAL INVESTIGATOR

• Monireh Ghazaeian

  mazandaran university of medical science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Neurology

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: February 18, 2020
• Study Start: August 22, 2020
• Primary Completion: April 10, 2023
• Study Completion: April 30, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: Data will be available for researchers and scientific persons after request and review the proposal .

Locations

IR (1)