Clinical trial NCT02024230: Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS)
Official title: Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Atrial Fibrillation
Stroke
Fetal Blood Loss
Major Bleeding
All Cause Mortality
Lead sponsor: Fujita Health University
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: a composite of adverse events
timeFrame: 3 years
measure: major bleeding
timeFrame: 3 years
measure: Net Adverse Clinical Event (NACE)
timeFrame: 3 years
Secondary outcomes:
measure: all-cause death
timeFrame: 3 years
measure: admission due to congestive heart failure
timeFrame: 3 years
measure: fatal arrhythmia
timeFrame: 3 years
measure: electrocardiographic findings
timeFrame: 3 years
measure: cardiac ultrasound findings
timeFrame: 3 years
measure: each cardiovascular event used for the primary efficacy outcome measures
timeFrame: 3 years
measure: non-major clinical relevant bleeding
timeFrame: 3 years
measure: cardiac or stroke death
timeFrame: 3 years
measure: non-fatal myocardial infarction
timeFrame: 3 years
measure: non-fatal stroke
timeFrame: 3 years
measure: coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)
timeFrame: 3 years
measure: systemic embolism
timeFrame: 3 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Yukio Ozaki
state: Aichi
Study officials:
References: