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

This study is currently recruiting participants.
Verified March 2015 by Yukio Ozaki, Fujita Health University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02024230
First Posted: December 31, 2013
Last Update Posted: March 18, 2015
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.
Collaborator:
Bayer Yakuhin, Ltd.
Information provided by (Responsible Party):
Yukio Ozaki, Fujita Health University
  Purpose
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 Intervention Phase
Coronary Artery Disease Atrial Fibrillation Stroke Fetal Blood Loss Drug: Warfarin or Rivaroxaban Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Yukio Ozaki, Fujita Health University:

Primary Outcome Measures:
  • 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

  • major bleeding [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • 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 [ 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)

  • 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

  • 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 ]

Estimated Enrollment: 1600
Study Start Date: May 2014
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Warfarin
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
Active Comparator: Rivaroxaban
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02024230


Locations
Japan
Fujita Health University Hospital Recruiting
Toyoake, Japan, 4701192
Contact: Yukio Ozaki, Prof., MD, PhD.    +81562932312    ozakiyuk@fujita-hu.ac.jp   
Sponsors and Collaborators
Fujita Health University
Bayer Yakuhin, Ltd.
  More Information

Responsible Party: Yukio Ozaki, Department of Cardiology, Fujita Health University, Fujita Health University
ClinicalTrials.gov Identifier: NCT02024230     History of Changes
Other Study ID Numbers: REWRAPS
First Submitted: December 10, 2013
First Posted: December 31, 2013
Last Update Posted: March 18, 2015
Last Verified: March 2015

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