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

Sponsor

Mazandaran University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04273516

Collaborator

(none)

Enrollment

Location

Arms

26.3

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stroke Prevention	Drug: Rivaroxaban 2.5 Mg Oral Tablet Drug: Rivaroxaban placebo tablets	Phase 2/Phase 3

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 22, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Tablet Rivaroxaban 2.5 mg 2 times daily plus ASA 80 mg daily	Drug: Rivaroxaban 2.5 Mg Oral Tablet Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily Other Names: Axabin 2.5
Placebo Comparator: Comparator Tab ASA 80 mg daily plus placebo ( similar to rivaroxaban tablet) 2 times daily	Drug: Rivaroxaban placebo tablets Placebo tablets add to ASA 80 mg daily that is standard treatment Other Names: Placebo

Arm

Intervention/Treatment

Experimental: Intervention

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

Drug: Rivaroxaban 2.5 Mg Oral Tablet

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

Other Names:

Axabin 2.5

Placebo Comparator: Comparator

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

Drug: Rivaroxaban placebo tablets

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

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Rate of stroke recurrence [Rate of stroke recurrence during one year fallow up]
Number of stroke events during 1 year of study
Rate of major bleeding [During 1 year of study]
Rate of major bleeding according to criteria of the International Society of Thrombosis and Hemostasis

Secondary Outcome Measures

Rate of stroke or systemic embolisms [During 1 year of study]
Number of stroke or systemic embolisms recurrence during 1 year of study
Mortality rate [During 1year of study]
Number of all cause mortality during study
Rate of non-major bleeding [During 1year of study]
Rate of non-major bleeding according to criteria of the International Society of Thrombosis and Hemostasis
Rate of intracranial bleeding [During 1year of study]
Rate of ICH during study
Rate of fatal bleeding [During 1 year of study]
Rate of fatal bleeding in any site

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bou- Ali Sina Hospital	Sari	Mazandaran	Iran, Islamic Republic of

Sponsors and Collaborators

Mazandaran University of Medical Sciences

Investigators

Principal Investigator: Athena Sharifi-Razvi, mazandaran university of medical science
Study Director: Monireh Ghazaeian, mazandaran university of medical science