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

Phase 4

Completed

• Conditions: Fetal Blood Loss; Major Bleeding; Atrial Fibrillation; All Cause Mortality; Coronary Artery Disease; Stroke
• Interventions: Drug: Rivaroxaban or Warfarin

• Registration Number: NCT02024230
• Lead Sponsor: Fujita Health University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-25
• Study First Posted: 2013-12-31
• Study Start: 2014-01
• Primary Completion: 2018-12
• Status Verified: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-29
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban or Warfarin	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)
Warfarin	Rivaroxaban or 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.)

Primary Outcome Measures

Name	Time	Method
a composite of adverse events	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
Net Adverse Clinical Event (NACE)	3 years	a composite of all-cause death and major bleeding
major bleeding	3 years	BARC 3 and 5

Secondary Outcome Measures

Name	Time	Method
fatal arrhythmia	3 years
non-fatal myocardial infarction	3 years
all-cause death	3 years
cardiac or stroke death	3 years
admission due to congestive heart failure	3 years
electrocardiographic findings	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)
each cardiovascular event used for the primary efficacy outcome measures	3 years
non-fatal stroke	3 years
non-major clinical relevant bleeding	3 years
coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)	3 years
cardiac ultrasound findings	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
systemic embolism	3 years

Trial Locations

Locations (1)

Yukio Ozaki; 🇯🇵 Nagoya, Aichi, Japan