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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02024230
Recruitment Status : Recruiting
First Posted : December 31, 2013
Last Update Posted : September 14, 2018
Bayer Yakuhin, Ltd.
Information provided by (Responsible Party):
Yukio Ozaki, Fujita Health University

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Atrial Fibrillation Stroke Fetal Blood Loss Drug: Warfarin or Rivaroxaban

Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
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.
Drug: Warfarin or Rivaroxaban
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

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.
Drug: Warfarin or Rivaroxaban
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

Primary Outcome Measures :
  1. composite of adverse events [ Time Frame: 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

  2. major bleeding [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. all-cause death [ Time Frame: 3 years ]
  2. admission due to congestive heart failure [ Time Frame: 3 years ]
  3. fatal arrhythmia [ Time Frame: 3 years ]
  4. electrocardiographic findings [ Time Frame: 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)

  5. cardiac ultrasound findings [ Time Frame: 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

  6. each cardiovascular event used for the primary efficacy outcome measures [ Time Frame: 3 years ]
  7. non-major clinical relevant bleeding [ Time Frame: 3 years ]
  8. cardiac or stroke death [ Time Frame: 3 years ]
  9. non-fatal myocardial infarction [ Time Frame: 3 years ]
  10. non-fatal stroke [ Time Frame: 3 years ]
  11. coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft) [ Time Frame: 3 years ]
  12. systemic embolism [ Time Frame: 3 years ]

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02024230

Fujita Health University Hospital Recruiting
Toyoake, Japan, 4701192
Contact: Yukio Ozaki, Prof., MD, PhD.    +81562932312   
Sponsors and Collaborators
Fujita Health University
Bayer Yakuhin, Ltd.

Responsible Party: Yukio Ozaki, Department of Cardiology, Fujita Health University, Fujita Health University Identifier: NCT02024230     History of Changes
Other Study ID Numbers: REWRAPS
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action