AFIRE Study: Atrial Fibrillation and Ischemic events with Rivaroxaban in patiEnts with stable coronary artery disease Study

Not Applicable

Completed

• Conditions: on-valvular atrial fibrillation

• Registration Number: JPRN-UMIN000016612
• Lead Sponsor: Japan Cardiovascular Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Study Completion: 2018-09-30
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients who are contraindicated for rivaroxaban 2)Patients who are contraindicated for aspirin, thienopyridine derivatives (clopidogrel or prasugrel) 3)Patients who underwent PCI, including POBA, in the past one year 4)Patients who are going to undergo revascularization 5)Patients who have a past history of stent thrombosis 6)Those who are going to undergo invasive surgery (excluding digestive endoscopy and biopsy) 7)Patients who have active tumors 8)Patients who have poorly-controlled hypertension (systolic blood pressure at hospital admission based on two or more measurements: 160 mmHg or more) 9)Patients who cannot discontinue treatment with antiplatelet drugs (the physician in charge will make a decision on the basis of the lesion shape, lesion site and type of stents.) (10)Patients judged as inappropriate for this study by investigators Contraindicated for rivaroxaban (1)Unstable CAD (2)Patients with a past history of stent thrombosis (3)Patients judged as inappropriate for this study by investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1)Primary efficacy endpoints Composite endpoint of cardiovascular events (stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularizations or all-cause mortality) (2)Safety primary endpoints Major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH)