NCT04273516

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Mazandaran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stroke
• Prevention

Interventions

Type	Name	Description
DRUG	Rivaroxaban 2.5 Mg Oral Tablet	Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily
DRUG	Rivaroxaban placebo tablets	Placebo tablets add to ASA 80 mg daily that is standard treatment

Timeline

• Start date: 2020-08-22
• Primary completion: 2023-04-10
• Completion: 2023-04-30
• First posted: 2020-02-18
• Last updated: 2023-10-19

Locations

1 site across 1 country: Iran

Regulatory

• FDA-regulated drug study