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

Stroke Clinical Trial

— REWRAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024230
• Other study ID #: REWRAPS
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: Fujita Health University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2022
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rivaroxaban or Warfarin
a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin

Locations

Country	Name	City	State
Japan	Yukio Ozaki	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Fujita Health University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	major bleeding	BARC 3 and 5	3 years
Primary	Net Adverse Clinical Event (NACE)	a composite of all-cause death and major bleeding	3 years
Secondary	all-cause death		3 years
Secondary	admission due to congestive heart failure		3 years
Secondary	fatal arrhythmia		3 years
Secondary	electrocardiographic findings	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
Secondary	cardiac ultrasound findings	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
Secondary	each cardiovascular event used for the primary efficacy outcome measures		3 years
Secondary	non-major clinical relevant bleeding		3 years
Secondary	cardiac or stroke death		3 years
Secondary	non-fatal myocardial infarction		3 years
Secondary	non-fatal stroke		3 years
Secondary	coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)		3 years
Secondary	systemic embolism		3 years