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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037403
Receipt No. R000042647
Scientific Title Retrospective analysis of the prospective cohort of patients with chronic heart failure on atrial fibrillation, cancer and anti-thrombolytic therapy: The CHART-2_Cancer_AF Study
Date of disclosure of the study information 2019/07/17
Last modified on 2019/07/17

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Basic information
Public title Retrospective analysis of the prospective cohort of patients with chronic heart failure on atrial fibrillation, cancer and anti-thrombolytic therapy: The CHART-2_Cancer_AF Study
Acronym The CHART-2_Cancer_AF Study
Scientific Title Retrospective analysis of the prospective cohort of patients with chronic heart failure on atrial fibrillation, cancer and anti-thrombolytic therapy: The CHART-2_Cancer_AF Study
Scientific Title:Acronym The CHART-2_Cancer_AF Study
Region
Japan

Condition
Condition Patients with chronic heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine incidence of cancer and other clinical outcomes in patients with chronic heart failure and atrial fibrillation with a reference to anti-thrombolytic therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A composite of stroke, systemic thromboembolism and ISTH major bleeding events
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 1) Structural heart disease but without signs or symptoms of heart failure.
2) Structural heart disease with prior or current symptoms of heart failure.
3) Refractory heart failure requiring specialized interventions.
4) Patients with prior cardiovascular surgery or percutaneous coronary intervention and those who need such interventions.
Key exclusion criteria None
Target sample size 10219

Research contact person
Name of lead principal investigator
1st name Yasuhiko
Middle name
Last name Sakata
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 980-8574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7153
Email sakatayk@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Kotaro
Middle name
Last name Nochioka
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 980-8574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7153
Homepage URL
Email nochioka@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Daiichi-Sankyo
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 Ethics Committee of Tohoku University Graduate School of Medicine
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 9808574 Japan
Tel +81-22-717-8007
Email med-kenkyo@grp.tohoku.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
2019 Year 07 Month 17 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 10219
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
2019 Year 03 Month 31 Day
Date of IRB
2018 Year 05 Month 16 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2019 Year 07 Month 17 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042647

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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