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

Phase 4CompletedNCT02024230

Fujita Health University500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Coronary Artery Disease Atrial Fibrillation Stroke Fetal Blood Loss

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 3 years

major bleeding

BARC 3 and 5

Time frame: 3 years

Net Adverse Clinical Event (NACE)

a composite of all-cause death and major bleeding

Time frame: 3 years

Secondary Outcomes

all-cause death

Time frame: 3 years

admission due to congestive heart failure

Time frame: 3 years

fatal arrhythmia

Time frame: 3 years

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)

Time frame: 3 years

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

Time frame: 3 years

each cardiovascular event used for the primary efficacy outcome measures

Time frame: 3 years

non-major clinical relevant bleeding

Time frame: 3 years

cardiac or stroke death

Time frame: 3 years

non-fatal myocardial infarction

Time frame: 3 years

non-fatal stroke

Time frame: 3 years

coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)

Time frame: 3 years

systemic embolism

Time frame: 3 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes