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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032829
Receipt No. R000037238
Scientific Title Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Rivaroxaban cohort Extension
Date of disclosure of the study information 2018/06/01
Last modified on 2020/11/25

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Basic information
Public title Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry
- Rivaroxaban cohort Extension
Acronym JACRE-REx
Scientific Title Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry
- Rivaroxaban cohort Extension
Scientific Title:Acronym JACRE-REx
Region
Japan

Condition
Condition Patients enrolled in [the previous study] who have not declared refusal to participation in this study according to an opt-out policy.
[The previous study]
Patients with nonvalvular atrial fibrillation [NVAF] who undergo catheter ablation.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of rivaroxaban, an oral factor Xa inhibitor, in patients with NVAF during the perioperative period of catheter ablation by retrospectively following up patients until the late postoperative period.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The combination of thromboembolism and serious bleeding during the late postoperative period after one month from catheter ablation.
- Thromboembolism: including transient ischemic attack, cerebral infarction, and other kinds of systemic embolism.
- Serious bleeding
Key secondary outcomes Occurrence (recurrence) of atrial fibrillation during the late postoperative period after one month from catheter ablation
Presence or absence of repeated ablation during the late postoperative period after one month from catheter ablation and its details
Stroke (ischemic)/TIA during the late postoperative period after one month from catheter ablation
Stroke (hemorrhagic) during the late postoperative period after one month from catheter ablation
Cardiovascular events during the late postoperative period after one month from catheter ablation
Serious bleeding during the late postoperative period after one month from catheter ablation
Not serious but clinically significant bleeding during the late postoperative period after one month from catheter ablation
Presence or absence of discontinuation of anticoagulant therapy during the late postoperative period after one month from catheter ablation

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Patients must meet all of the following conditions to be eligible for the study.
1] Diagnosis of nonvalvular atrial fibrillation [NVAF].
NVAF refers to atrial fibrillation without history of rheumatic mitral valve disease, prosthetic valve, or mitral valve repair.
2] Undergoing ablation therapy [radiofrequency ablation only] for the treatment of atrial fibrillation.
3] Receiving rivaroxaban for at least 3 weeks by the time of hospitalization for catheter ablation.
4] Age 20years and older at providing consent.
5] Written informed consent must be obtained from the patient, unless the following condition does not apply. If, upon approval by the Ethics Review Committee, information on the study has been properly disclosed to the target patients through means such as poster presentations in the study site, obtaining written informed consent can be exempted so that the patient will be excluded from the study only when she/he declares refusal to enrollment in the study.
Key exclusion criteria Patients will be excluded from the study if any of the following conditions apply.
1] Contraindication to ablation therapy for the treatment of atrial fibrillation [e.g., due to a preoperative transesophageal echocardiography, CT, or MRI finding of a thrombus in the left atrium/left atrial appendage].
2] Development of thromboembolism or myocardial infarction within 2 months before enrollment.
3] Contraindication to Rivaroxaban.
4] For a study site that is allowed to omit the procedure of obtaining written informed consent, a patient who declares refusal to enrollment in the study will be excluded.
5] Current participation in another interventional clinical study.
6] The investigator's judgement that the patient will be inappropriate for participation in the study.
Target sample size 1118

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Okumra
Organization Saiseikai Kumamoto Hospital
Division name Cardiovascular medicine, Division of Arrhythmia treatment category
Zip code 861-4193
Address 5-3-1,Chikami Minami-Ku Kumamoto-City Kumamoto,Japan
TEL 096-351-8000
Email okumura@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Fujihiro
Organization A2 Healthcare Corporation
Division name Clinical Development Promotion Dept.
Zip code 112
Address 1-4-1,Koishikawa,Bunkyo-Ku, Tokyo, JAPAN
TEL 03-3830-1075
Homepage URL
Email JACRE_Ex@a2healthcare.com

Sponsor
Institute Reimeikyo
Institute
Department

Funding Source
Organization Bayer Yakuhin,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Saiseikai Kumamoto Hospital
Address 5-3-1,Chikami Minami-Ku Kumamoto-City Kumamoto,Japan
Tel 096-351-8000
Email JACRE_Ex@a2healthcare.com

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
2018 Year 06 Month 01 Day

Related information
URL releasing protocol https://www.sciencedirect.com/science/article/abs/pii/S0914508720302999
Publication of results Published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/abs/pii/S0914508720302999
Number of participants that the trial has enrolled 823
Results Long-term incidence of thromboembolism was extremely low in patients with AF treated with CA, while that of major bleeding was not necessarily low.
Results date posted
2020 Year 11 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Data of 975 patients(rivaroxaban,n=823;warfarin,n=152)were collected from 27 institutes.Patient population had mean age 63.7+-10.3 years,710(72.8%)males,mean CHA2DS2-VASc score 1.9+-1.5,and mean follow-up period 28.7+-12.7 months after the index procedure.Anticoagulants were continued in 496(50.9%)patients during the follow-up.
Participant flow We established a prospective registry, called the JACRE registry, for patients on rivaroxaban or warfarin administration who received CA for AF. The outcomes up to 30 days following the procedure were reported previously. The present study involved a longer follow-up of patients enrolled in this registry to evaluate long-term anticoagulation strategies and clinical outcomes.
Adverse events Thromboembolism occurred in 3 patients, hemorrhagic stroke in 5, and major bleeding events in 9 (annualized event rate, 0.13%, 0.22%, and 0.40% per patient-year, respectively).
Outcome measures Composite of thromboembolism and severe bleeding events after 1 month of catheter ablation treatment.
Thromboembolism; transient ischemic attack, stroke, and other systemic embolism
Serious bleeding
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 04 Month 19 Day
Date of IRB
2018 Year 05 Month 30 Day
Anticipated trial start date
2018 Year 06 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 04 Month 30 Day
Date analysis concluded
2019 Year 06 Month 26 Day

Other
Other related information In VENTURE-AF study, post-ablation incidences of thromboembolism and bleeding events in patients treated with rivaroxaban were reported not to differ from those treated with warfarin. In a double-blind study ROCKET-AF, rivaroxaban, an oral factor Xa inhibitor, was shown to be non-inferior to warfarin for prophylactic effects against NVAF-related <stroke and systemic embolism>.

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2020 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037238

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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