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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024206
Receipt No. R000027872
Scientific Title Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS:prospective observational study)
Date of disclosure of the study information 2016/10/17
Last modified on 2016/09/28

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Basic information
Public title Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS:prospective observational study)
Acronym REWRAPS Study (prospective observational study)
Scientific Title Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS:prospective observational study)
Scientific Title:Acronym REWRAPS Study (prospective observational 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 Non-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 are not willing to participate in the study
Target sample size 1600

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
2016 Year 10 Month 17 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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 28 Day
Last modified on
2016 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027872

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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