UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Real-world EValuation of the antithrombotic thErapy And clinicaL outcomes for the patients with Atrial Fibrillation undergoing Percutaneous Coronary Intervention
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takeshi Kimura
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
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	Toshiaki Toyota
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 09 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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