UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015531 |
|---|---|
| Receipt number | R000018032 |
| Scientific Title | Multicenter Registry for the Optimal Antithrombotic Therapy in the Patients with Arial Fibrillation Undergoing Percutaneous Coronary Intervention Study |
| Date of disclosure of the study information | 2014/10/26 |
| Last modified on | 2023/11/02 13:11:55 |
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Basic information
Public title
Multicenter Registry for the Optimal Antithrombotic Therapy in the Patients with Arial Fibrillation Undergoing Percutaneous Coronary Intervention Study
Acronym
MILESTONE Study
Scientific Title
Multicenter Registry for the Optimal Antithrombotic Therapy in the Patients with Arial Fibrillation Undergoing Percutaneous Coronary Intervention Study
Scientific Title:Acronym
MILESTONE Study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this registry study is to investigate the management of antiplatelet and oral anticoagulant therapies and the frequencies of cardiovascular events, stent thrombosis, and bleeding events in patients who have undergone stent implantation in actual clinical settings.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bleeding events at just after PCI, 30 days and 1 year follow-up
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone PCI with EES
Key exclusion criteria
Patients who have already been implanted other DES
Patiens with acute myocardial infarction
Patients judged by the treating physician to be unsuitable as study subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Ako |
Organization
Kitasato University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374 Japan
TEL
0427788111
hidehira@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidehira |
| Middle name | |
| Last name | Fukaya |
Organization
Kitasato University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374 Japan
TEL
042-778-8111
Homepage URL
hidehira@med.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Abbott Vascular Japan
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
IRB, Kitasato University School of Medicine
Address
1-15-1, Kitasato, Minami-ku
Tel
042-778-7756
onoya@kitasato-u.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
| 2014 | Year | 10 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary Endpoint
Bleeding events at just after PCI, 30 days and 1 year follow-up
Secondary Endpont
Following events at jst after PCI, 30 days and 1 year follow-up
-Cardiovascular event
- Myocardial infarction
- Revasclarization (PCI or CABG)
-Death (cardiac or non-cardiac)
-Stroke
-Heart Failure
-Stent thrombosis (ARC definition)
Management information
Registered date
| 2014 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018032
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
