Unique ID issued by UMIN | UMIN000014817 |
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Receipt number | R000017087 |
Scientific Title | Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Rivaroxaban cohort |
Date of disclosure of the study information | 2014/08/11 |
Last modified on | 2016/11/24 16:07:15 |
Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Rivaroxaban cohort
JACRE-R
Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Rivaroxaban cohort
JACRE-R
Japan |
Non-valvular atrial fibrillation patients scheduled to undergo the catheter ablation procedure
Cardiology |
Others
NO
To evaluate effectiveness and safety of practical uses of rivaroxaban in peri-procedure of catheter ablation in patients with non-valvular atrial fibrillation
Safety,Efficacy
Composite of thromboembolic events and major bleedings within 1 month since catheter ablation procedure
-Thromboembolic events; transient ischemic attack, ischemic stroke, non-CNS systemic embolism
- Major bleeding; pericardial effusion requiring a drainage procedure (cardiac tamponade),puncture hematoma requiring surgery, other bleeding episodes requiring blood transfusion, intracranial hemorrhage
- Thromboembolism within 1 month since catheter ablation procedure
- Major bleeding within 1 month since catheter ablation procedure
- Non-major bleeding within 1 month since catheter ablation procedure
- Composite of thromboembolism and major bleeding within 1 month since catheter ablation procedure in a group of patients for whom the oral anticoagulation therapy was interrupted on the day of catheter ablation (interrupted regimen group) and in another group for whom the oral anticoagulation therapy was administered on the day of catheter ablation procedure (uninterrupted regimen group)
- Non-major bleeding within 1 month since catheter ablation procedure in a group of patients for whom the oral anticoagulation therapy was interrupted on the day of catheter ablation (interrupted regimen group) and in another group for whom the oral anticoagulation therapy was administered on the day of catheter ablation (uninterrupted regimen group)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Non-valvular atrial fibrillation patients scheduled to undergo the catheter ablation procedure and to have been receiving rivaroxaban for at least 3 weeks at the time of admission for catheter ablation procedure
Patients for whom catheter ablation for atrial fibrillation is contraindicated
Patients with a history of thromboembolism or myocardial infarction within 2 months prior to enrollment
1100
1st name | |
Middle name | |
Last name | Ken Okumura |
Hirosaki University Graduate School of Medicine
Department of Cardiology
5, Zaifu-cho, Hirosaki, Aomori, 036-8562 Japan
0172-33-5111
okumura@cc.hirosaki-u.ac.jp
1st name | |
Middle name | |
Last name | Bell Medical Solutions, Inc. |
Bell Medical Solutions, Inc.
Clinical Research and Development Division
Bunkyo Green Court, 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, JAPAN
0120-291-335
jimukyoku@medical-bs24.com
Reimeikyou
Bayer Yakuhin, Ltd.
Profit organization
NO
2014 | Year | 08 | Month | 11 | Day |
Published
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-16-0621/_article
The rates of thromboembolism and major bleeding events during the AF ablation perioperative period in Japanese patients treated with rivaroxaban was as low as in those treated with warfarin.
Completed
2014 | Year | 04 | Month | 21 | Day |
2014 | Year | 07 | Month | 16 | Day |
2015 | Year | 09 | Month | 15 | Day |
2015 | Year | 09 | Month | 20 | Day |
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 12 | Month | 31 | Day |
In the post-hoc analysis of rivaroxaban in the ROCKET AF study, no differences in the incidence rates of thromboembolism and hemorrhagic events after ablation compared to those after warfarin treatment were reported. However, these data were obtained from a limited number of patients, all with high CHADS2 risk scores, compared to the target patient population for ablation in actual clinical practice.
A recent registered observational study by Lakkireddy et al. reported that the efficacy and safety of the uninterrupted rivaroxaban after the evening meal and the uninterrupted Vitamin K antagonist were comparable.
2014 | Year | 08 | Month | 11 | Day |
2016 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017087
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