UMIN-CTR Clinical Trial

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

Atrial fibrillation, Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Fujita Health University, Department of Cardiology

Institute

Department

Personal name

Organization

Fujita Health University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

03

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

03

Month

23

Day

Last modified on

2018

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019429