UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038841 |
|---|---|
| Receipt number | R000044293 |
| Scientific Title | Safety of Intervention by Cardiac Implantable Electronic Devices and Catheter Ablation in Patients on Anticoagulants |
| Date of disclosure of the study information | 2019/12/11 |
| Last modified on | 2025/06/16 14:24:22 |
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Basic information
Public title
Safety of Intervention by Cardiac Implantable Electronic Devices and Catheter Ablation in Patients on Anticoagulants
Acronym
Safety of Cardiac Devices and Ablation in Patients on Anticoagulants
Scientific Title
Safety of Intervention by Cardiac Implantable Electronic Devices and Catheter Ablation in Patients on Anticoagulants
Scientific Title:Acronym
Safety of Cardiac Devices and Ablation in Patients on Anticoagulants
Region
| Japan |
Condition
Condition
arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to reveal the outcome of CIED intervention and catheter ablation in patients on anticoagulant.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
procedure related complications
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study consists of patients undergoing CIED intervention or catheter ablation, identified with ICD-10 diagnosis codes (K595, 597, 598, 599)
Key exclusion criteria
none
Target sample size
9264
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Miyamoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
koji3koji3@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Miyamoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
koji3koji3@gmail.com
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
JRISTA
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, National Cerebral and Cardiovascular Center
Address
6-1, Kishibeshinmachi, Suita, Osaka
Tel
06-6170-1070
rec-office-ac@ncvc.go.jp
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
| 2019 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36687335/
Number of participants that the trial has enrolled
6564
Results
The overall complication incidence was significantly lower in the NOACs group than in the warfarin group. Although no significant differences in the incidence of cardiac tamponade and major bleeding were noted, blood transfusion requirements and vascular complications were significantly lower in the NOACs group than in the warfarin group. Furthermore, the thromboembolic event incidence was significantly lower in the NOACs group than in the warfarin group.
Results date posted
| 2025 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 67.4 years and 67.3 years in the NOACs and warfarin groups, respectively, and 27.7 % of the patients were female. Among the patients, 45.1 % had heart failure, 53.6 % hypertension, 20.4 % diabetes mellitus, 28.1 % hyperlipidemia, 1.8 % stroke or TIA, 20.6 % ischemic heart disease, and 20.8 % concomitant antiplatelet drug use. The patients in the NOACs group were prescribed dabigatran (N =581), rivaroxaban (N =923), apixaban (N =784), or edoxaban (N =994).
Participant flow
NA
Adverse events
See results
Outcome measures
Complication rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint
1. Major bleeding events defined according to the International Society on Thrombosis and Hemostasis criteria
2. Thromboembolic events (cerebral infarction, transient ischemic attack, systemic embolism)
3. Cardiac tamponade
4. Vascular injury required surgery
5. Death on discharge
Management information
Registered date
| 2019 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044293
