All Cause Mortality, Atrial Fibrillation, Coronary Artery Disease, Fetal Blood Loss, Major Bleeding, Stroke
Conditions
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
Interventions
DRUGRivaroxaban or Warfarin
a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin
Sponsors
Fujita Health University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| major bleeding | 3 years | BARC 3 and 5 |
| Net Adverse Clinical Event (NACE) | 3 years | a composite of all-cause death and major bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| each cardiovascular event used for the primary efficacy outcome measures | 3 years | — |
| non-major clinical relevant bleeding | 3 years | — |
| all-cause death | 3 years | — |
| non-fatal myocardial infarction | 3 years | — |
| non-fatal stroke | 3 years | — |
| coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft) | 3 years | — |
| systemic embolism | 3 years | — |
| cardiac or stroke death | 3 years | — |
| admission due to congestive heart failure | 3 years | — |
| fatal arrhythmia | 3 years | — |
Countries
Japan
Outcome results
None listed