UMIN-CTR Clinical Trial

Basic information
Public title	Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS)
Acronym	REWRAPS Study
Scientific Title	Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS)
Scientific Title:Acronym	REWRAPS Study
Region	Japan

Condition
Condition	Atrial fibrillation, Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the efficacy and safety for AF patients after coronary stenting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy; composite of adverse events [cardiac or stroke death, non-fatal myocardial infarction, non-fatal stroke, and coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft), and systemic embolism] Safety; major bleeding or non-major clinically relevant bleeding
Key secondary outcomes	All-cause death non-fatal myocardial infarction coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft) admission due to congestive heart failure fatal arrhythmia non-fatal stroke systemic embolism stent thrombosis major bleeding non-major clinical relevant bleeding electrocardiographic findings 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 left atrial dilatation (LAD), left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs), E/A, tricuspid regurgitation pressure gradient (TRPG), LV wall abnormality

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rivaroxaban
Interventions/Control_2	Warfarin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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 have moderate renal insufficiency (creatinine clearance less than 30 ml/min) Those who have severe hepatic insufficiency [ALT more than five times the upper limit of normal (ULN), or ALT more than three times ULN, plus total bilirubin more than three times ULN] Those who have anemia (hemoglobin less than 10 g/dl) Those who are not willing to participate in the study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukio Ozaki
Organization	Fujita Health University
Division name	Cardiology
Zip code
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192
TEL	0562-93-2312
Email	ozakiyuk@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideki Kawai
Organization	Fujita Health University
Division name	Cardiology
Zip code
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192
TEL	0562-93-2312
Homepage URL
Email	hkawai@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University, Department of Cardiology
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 23 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019429

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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