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

December 29, 2022 updated by: Yukio Ozaki, Fujita Health University
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

Study Overview

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aichi
      • Nagoya, Aichi, Japan, 461-0021
        • Yukio Ozaki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin
Active Comparator: 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.)
a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a composite of adverse events
Time Frame: 3 years
cardiac or stroke death, non-fatal myocardial infarction, non-fatal stroke, coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft), and systemic embolism
3 years
major bleeding
Time Frame: 3 years
BARC 3 and 5
3 years
Net Adverse Clinical Event (NACE)
Time Frame: 3 years
a composite of all-cause death and major bleeding
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death
Time Frame: 3 years
3 years
admission due to congestive heart failure
Time Frame: 3 years
3 years
fatal arrhythmia
Time Frame: 3 years
3 years
electrocardiographic findings
Time Frame: 3 years
rhythm, ST change, Q wave abnormality, QRS duration, QT interval, QTc interval, the presence of supraventricular premature contraction (SVPC), the presence of ventricular premature contraction (VPC)
3 years
cardiac ultrasound findings
Time Frame: 3 years
left atrial dilatation (LAD), left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs), E/A, E/E', tricuspid regurgitation pressure gradient (TRPG), LV wall abnormality
3 years
each cardiovascular event used for the primary efficacy outcome measures
Time Frame: 3 years
3 years
non-major clinical relevant bleeding
Time Frame: 3 years
3 years
cardiac or stroke death
Time Frame: 3 years
3 years
non-fatal myocardial infarction
Time Frame: 3 years
3 years
non-fatal stroke
Time Frame: 3 years
3 years
coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)
Time Frame: 3 years
3 years
systemic embolism
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 25, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

January 2, 2023

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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