Overview

Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the prevention of cardiogenic embolism including cerebral infarction in AF patients. However, the combined antithrombotic therapy has been reported to increase the risk of major bleeding for AF patients after coronary stenting, New anticoagulant drugs that hardly interact with other drugs and do not need frequent blood tests have become commonly used. The purpose of this study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the efficacy and safety for AF patients after coronary stenting.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fujita Health University
Collaborator:
Bayer Yakuhin, Ltd.
Treatments:
Rivaroxaban
Warfarin
Criteria
Inclusion Criteria:

- Clinically stable atrial fibrillation (AF) patients who underwent coronary artery
stenting more than one year ago and are treated or are scheduled to be treated with
anticoagulant drug (regardless of the type of stents and AF).

- Those who are willing to cooperate with us in the study

- Those who can sign the informed consent document that is approved by the ethics
committee of the medical institution participating in the study

Exclusion Criteria:

- Those in whom the package inserts state anticoagulant drugs are contraindicated for
use

- Those who are scheduled to undergo percutaneous coronary intervention or catheter
ablation for AF

- Those who have to continuously undergo dual antiplatelet due to a past history of
stent thrombosis during the distant stage after stenting

- Those who have undergone prosthetic valve replacement for valvular disease

- Those who the physician in charge judges are ineligible for the study due to serious
pathological conditions

- Those who are not willing to participate in the study