- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024230
Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS) (REWRAPS)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Aichi
-
Nagoya, Aichi, Japan, 461-0021
- Yukio Ozaki
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rivaroxaban
Patients were treated over a median of 4.75 years with either rivaroxaban (10 mg once daily for patients with a creatinine clearance of 15-49 mL/min or 15 mg once daily for patients with a creatinine clearance ≥50 mL/min)
|
a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin
|
Active Comparator: Warfarin
The dose of warfarin can be controlled with dose adjustment to achieve a target international normalized ratio [INR] of 2.0-3.0 or in patients aged >70 years and having a high bleeding risk, a target INR of 1.6-2.6)
according to the guideline of Japanese Circulation Society based on the following paper (Inoue H, Okumura K, Atarashi H, Yamashita T, Origasa H, Kumagai N, et al.
Target international normalized ratio values for preventing thromboembolic and hemorrhagic events in Japanese patients with non-valvular atrial fibrillation: results of the J-RHYTHM Registry.
Circ J 2013;77(9):2264-70.)
|
a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
a 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
|
3 years
|
major bleeding
Time Frame: 3 years
|
BARC 3 and 5
|
3 years
|
Net Adverse Clinical Event (NACE)
Time Frame: 3 years
|
a composite of all-cause death and major bleeding
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all-cause death
Time Frame: 3 years
|
3 years
|
|
admission due to congestive heart failure
Time Frame: 3 years
|
3 years
|
|
fatal arrhythmia
Time Frame: 3 years
|
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)
|
3 years
|
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
|
3 years
|
each cardiovascular event used for the primary efficacy outcome measures
Time Frame: 3 years
|
3 years
|
|
non-major clinical relevant bleeding
Time Frame: 3 years
|
3 years
|
|
cardiac or stroke death
Time Frame: 3 years
|
3 years
|
|
non-fatal myocardial infarction
Time Frame: 3 years
|
3 years
|
|
non-fatal stroke
Time Frame: 3 years
|
3 years
|
|
coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)
Time Frame: 3 years
|
3 years
|
|
systemic embolism
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Arrhythmias, Cardiac
- Coronary Disease
- Coronary Artery Disease
- Atrial Fibrillation
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
- Warfarin
Other Study ID Numbers
- REWRAPS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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