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

NCT02024230 | Completed Phase 4 DMC

• 1 other identifier: REWRAPS
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• a composite of adverse events

  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

  BARC 3 and 5

  3 years

• Net Adverse Clinical Event (NACE)

  a composite of all-cause death and major bleeding

  3 years

Secondary Outcomes (12)

• all-cause death

  3 years

• admission due to congestive heart failure

  3 years

• fatal arrhythmia

  3 years

• electrocardiographic findings

  3 years

• cardiac ultrasound findings

  3 years

Study Arms (2)

Rivaroxaban

ACTIVE COMPARATOR

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)

Drug: Rivaroxaban or Warfarin

Warfarin

ACTIVE COMPARATOR

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.)

Drug: Rivaroxaban or Warfarin

Interventions

Rivaroxaban or Warfarin DRUG

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

Rivaroxaban; Warfarin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujita Health University: lead

Study Sites (1)

Yukio Ozaki

Nagoya, Aichi-ken, 461-0021, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation; Stroke

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Cardiology, Fujita Health University

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

JP (1)