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Recruitment status
Unique ID issued by UMIN UMIN000022004
Receipt No. R000025357
Scientific Title Real-world EValuation of the antithrombotic thErapy And clinicaL outcomes for the patients with Atrial Fibrillation undergoing Percutaneous Coronary Intervention
Date of disclosure of the study information 2016/05/01
Last modified on 2016/04/20

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Basic information
Public title Real-world EValuation of the antithrombotic thErapy And clinicaL outcomes for the patients with Atrial Fibrillation undergoing Percutaneous Coronary Intervention
Acronym REVEAL AF-PCI Registry
Scientific Title Real-world EValuation of the antithrombotic thErapy And clinicaL outcomes for the patients with Atrial Fibrillation undergoing Percutaneous Coronary Intervention
Scientific Title:Acronym REVEAL AF-PCI Registry
Region
Japan

Condition
Condition Atrial Fibrillation
Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the status of the antiplatelet regimen and clinical outcomes among atrial fibrillation patients treated with percutaneous coronary intervetion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite of death, myocardial infarction, stent thrombosis, stroke, and systemic embolism at 1-year from the index percutaneous coronary intervention.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients treated by percutaneous coronary intervention (PCI).
2. Patients diagnosed as atrial fibrillation at the time of index PCI.
Key exclusion criteria Patients who denied participation.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL 075-751-4255
Email totoyota@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Toyota
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL 075-751-4255
Homepage URL
Email totoyota@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Clinical Epidemiology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 R0185
Org. issuing International ID_1 Kyoto University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 01 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
Date of protocol fixation
2015 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis of antiplatelet regimen, patient baseline characteristics, and the details of the PCI procedures will be performed.

Management information
Registered date
2016 Year 04 Month 20 Day
Last modified on
2016 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025357

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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