UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022004 |
|---|---|
| Receipt number | 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 20:07:02 |
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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
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
totoyota@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Clinical Epidemiology, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025357
