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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Fujita Health University
Sponsor:
Collaborator:
Bayer Yakuhin, Ltd.
Information provided by (Responsible Party):
Yukio Ozaki, Fujita Health University
ClinicalTrials.gov Identifier:
NCT02024230
First received: December 10, 2013
Last updated: May 19, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Fujita Health University:

Primary Outcome Measures:
  • composite of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all-cause death [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • admission due to congestive heart failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • fatal arrhythmia [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • electrocardiographic findings [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • non-major clinical relevant bleeding [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • cardiac or stroke death [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • non-fatal myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • non-fatal stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • systemic embolism [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: May 2014
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 10, 2013
Last Updated: May 19, 2014
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Rivaroxaban
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014