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

Stroke Clinical Trial

— AREST-ESUS  

Official title:

Aspirin Plus Rivaroxaban Efficacy and Safety in Embolic Stroke of Undetermined Source: A Randomized, Placebo Controlled, Outcome Assessor Blind, Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273516
• Other study ID #: 3498
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 22, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2023
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 30, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolic Stroke
• Prevention
• Stroke

Intervention

Drug:
• Rivaroxaban 2.5 Mg Oral Tablet
Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily
• Rivaroxaban placebo tablets
Placebo tablets add to ASA 80 mg daily that is standard treatment

Locations

Country	Name	City	State
Iran, Islamic Republic of	Bou- Ali Sina Hospital	Sari	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of stroke recurrence	Number of stroke events during 1 year of study	Rate of stroke recurrence during one year fallow up
Primary	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	Rate of stroke or systemic embolisms	Number of stroke or systemic embolisms recurrence during 1 year of study	During 1 year of study
Secondary	Mortality rate	Number of all cause mortality during study	During 1year of study
Secondary	Rate of non-major bleeding	Rate of non-major bleeding according to criteria of the International Society of Thrombosis and Hemostasis	During 1year of study
Secondary	Rate of intracranial bleeding	Rate of ICH during study	During 1year of study
Secondary	Rate of fatal bleeding	Rate of fatal bleeding in any site	During 1 year of study