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

Primary Purpose

Stroke, Prevention

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Rivaroxaban 2.5 Mg Oral Tablet

Rivaroxaban placebo tablets

About this trial

This is an interventional prevention trial for Stroke focused on measuring ESUS, DOACS, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

signing the inform consent
recent ischemic stroke ( 7-60) days with criteria of ESUS
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:

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

Sites / Locations

Bou- Ali Sina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of stroke recurrence

Number of stroke events during 1 year of study

Rate of major bleeding

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

Secondary Outcome Measures

Rate of stroke or systemic embolisms

Number of stroke or systemic embolisms recurrence during 1 year of study

Mortality rate

Number of all cause mortality during study

Rate of non-major bleeding

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

Rate of intracranial bleeding

Rate of ICH during study

Rate of fatal bleeding

Rate of fatal bleeding in any site

Full Information

NCT ID

NCT04273516

First Posted

February 15, 2020

Last Updated

October 18, 2023

Sponsor

Mazandaran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04273516

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

August 22, 2020 (Actual)

Primary Completion Date

April 10, 2023 (Actual)

Study Completion Date

April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mazandaran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Prevention

Keywords

ESUS, DOACS, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Comparator

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban 2.5 Mg Oral Tablet

Other Intervention Name(s)

Axabin 2.5

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban placebo tablets

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of stroke recurrence

Description

Number of stroke events during 1 year of study

Time Frame

Rate of stroke recurrence during one year fallow up

Title

Rate of major bleeding

Description

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

Time Frame

During 1 year of study

Secondary Outcome Measure Information:

Title

Rate of stroke or systemic embolisms

Description

Number of stroke or systemic embolisms recurrence during 1 year of study

Time Frame

During 1 year of study

Title

Mortality rate

Description

Number of all cause mortality during study

Time Frame

During 1year of study

Title

Rate of non-major bleeding

Description

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

Time Frame

During 1year of study

Title

Rate of intracranial bleeding

Description

Rate of ICH during study

Time Frame

During 1year of study

Title

Rate of fatal bleeding

Description

Rate of fatal bleeding in any site

Time Frame

During 1 year of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Athena Sharifi-Razvi

Organizational Affiliation

mazandaran university of medical science

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Monireh Ghazaeian

Organizational Affiliation

mazandaran university of medical science

Official's Role

Study Director

Facility Information:

Facility Name

Bou- Ali Sina Hospital

City

Sari

State/Province

Mazandaran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Access Criteria

Data will be available for researchers and scientific persons after request and review the proposal .

Learn more about this trial

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

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