Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Coronary Artery Disease Atrial Fibrillation Stroke Fetal Blood Loss Major Bleeding All Cause Mortality

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rivaroxaban

Patients were treated over a median of 4.75 years with either rivaroxaban (10 mg once daily for patients with a creatinine clearance of 15-49 mL/min or 15 mg once daily for patients with a creatinine clearance ≥50 mL/min)

Group Type ACTIVE_COMPARATOR

Rivaroxaban or Warfarin

Intervention Type DRUG

a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin

Warfarin

The dose of warfarin can be controlled with dose adjustment to achieve a target international normalized ratio \[INR\] of 2.0-3.0 or in patients aged \>70 years and having a high bleeding risk, a target INR of 1.6-2.6) according to the guideline of Japanese Circulation Society based on the following paper (Inoue H, Okumura K, Atarashi H, Yamashita T, Origasa H, Kumagai N, et al. Target international normalized ratio values for preventing thromboembolic and hemorrhagic events in Japanese patients with non-valvular atrial fibrillation: results of the J-RHYTHM Registry. Circ J 2013;77(9):2264-70.)

Group Type ACTIVE_COMPARATOR

Rivaroxaban or Warfarin

Intervention Type DRUG

a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin

Interventions

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Rivaroxaban or Warfarin

a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No