Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation "REWRAPS"

Recruiting

Phase 4 Results N/A

Trial Description

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

Interventions

  • Warfarin or Rivaroxaban Drug
    Intervention Desc: No limitations of previous medication (Warfarin or new oral anticoagulant drugs or no anticoagulant drug) and type of stent (bare metal stent or drug eluting stent) in both arms
    ARM 1: Kind: Experimental
    Label: Warfarin
    Description: The dose of warfarin can be controlled so that the PT-INR value will be 2.0-3.0 in those aged under 70 years and 1.6-2.6 in those aged 70 years or more.
    ARM 2: Kind: Experimental
    Label: Rivaroxaban
    Description: A dose of 15 mg of rivaroxaban is orally administered to adults once a day. The dose can be reduced to 10 mg in patients with renal insufficiency (creatinine clearance: 30-49 mL/minute), patients at a high risk of hemorrhage (HAS-BLED score), old patients aged 75 years or more, and low body weight patients.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary composite of adverse events 3 years No
Primary major bleeding 3 years Yes
Secondary all-cause death 3 years No
Secondary admission due to congestive heart failure 3 years No
Secondary fatal arrhythmia 3 years No
Secondary electrocardiographic findings 3 years No
Secondary cardiac ultrasound findings 3 years No
Secondary each cardiovascular event used for the primary efficacy outcome measures 3 years No
Secondary non-major clinical relevant bleeding 3 years Yes
Secondary cardiac or stroke death 3 years No
Secondary non-fatal myocardial infarction 3 years No
Secondary non-fatal stroke 3 years No
Secondary coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft) 3 years No
Secondary systemic embolism 3 years No

Sponsors