UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031954 |
|---|---|
| Receipt number | R000036477 |
| Scientific Title | Relationship between temporal biomarker profiling after atrial fibrillation catheter ablation and the atrial fibrillation recurrence and thromboembolic event |
| Date of disclosure of the study information | 2018/03/28 |
| Last modified on | 2021/09/29 11:11:27 |
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Basic information
Public title
Relationship between temporal biomarker profiling after atrial fibrillation catheter ablation and the atrial fibrillation recurrence and thromboembolic event
Acronym
Temporal biomarker profiling after atrial fibrillation catheter ablation
Scientific Title
Relationship between temporal biomarker profiling after atrial fibrillation catheter ablation and the atrial fibrillation recurrence and thromboembolic event
Scientific Title:Acronym
Temporal biomarker profiling after atrial fibrillation catheter ablation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with atrial fibrillation on edoxaban treatment who undergo catheter ablation, various biomarkers will be measured . This study will investigate the relation between temporal profile of various biomarkers and recurrence of atrial fibrillation and onset of thromboembolic/ bleeding events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between temporal changes of various biomarkers before and after catheter ablation of atrial fibrillation and recurrence of atrial fibrillation.
Before catheter ablation, immediately after ablation, 1 day after ablation, at 1, 3, and 6 months after ablation, and at recurrence of atrial fibrillation
cTnT, NT-proBNP, PT-INR, APT, D-dimer, SFMC, TAT, PT fragment F1+2, Fib, AT-III, t-PA, PAI-1, vWf, sTM
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a confirmed diagnosis of atiral fibrillation who are scheduled to undergo catheter ablation.
Patients who have used edoxaban prior to enrollment in this study.
Patients who are 20 or more than 20 years old.
Patients who receive an explanation about this study and give written informed consent (sequential registration, in principle).
Key exclusion criteria
Patients scheduled to enroll in or participating in another clinical study.
Patients in whom catheter ablation is contraindicated.
Patients considered to be unsuitable for this study for other reasons.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Iwasaki |
Organization
Nippon Medical School
Division name
The department of cardiovascular medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
iwasaki@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Iwasaki |
Organization
Nippon Medical School Hospital
Division name
The department of cardiovascular medicine
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
iwasaki@nms.ac.jp
Sponsor or person
Institute
Nipopn Medical School
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
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
Nippon Medical School
Address
1-1-5 Sengagi, Bunkyo-ku Tokyo
Tel
0338222131
iwasaki@nms.ac.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
| 2018 | Year | 03 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient demographic profile: At registration
Epidemiological parameters (sex, age, height, body weight, etc.)
Disease status (severity, complications, concomitant drugs, etc.)
Biomarker assays:
Before catheter ablation, immediately after ablation, 1 day after ablation, at 1, 3, and 6 months after ablation, and at recurrence of atrial fibrillation
cTnI, NT-proBNP, PT-INR, APT, D-dimer, SFMC, TAT, PT fragment F1+2, Fib, ATIII, t-PA, PAI-1, FPA, vWf, TM
ECG:
Portable ECG:Twice daily for 6 months (30 seconds each time) and at the onset of symptoms
Holter ECG:3 and 6 months after ablation
Thromboembolic/Bleeding events: From the start to end of the study
1.Stroke
2.Systemic embolism, etc.
3.Major bleeding
4.Clinically relevant non-major bleeding
Adverse events: From the start to end of the study
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036477
