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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031954
Receipt No. 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 2018/09/27

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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
Middle name
Last name Yuki Iwasaki
Organization Nippon Medical School
Division name The department of cardiovascular medicine
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email iwasaki@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Iwasaki
Organization Nippon Medical School Hospital
Division name The department of cardiovascular medicine
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email iwasaki@nms.ac.jp

Sponsor
Institute Nipopn Medical School
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 30 Day
Last follow-up date
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
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036477

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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