UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039050 |
|---|---|
| Receipt number | R000044503 |
| Scientific Title | Tokyo / Kanagawa / Chiba / Shizuoka / Ibaraki active OCT applications for ACS (TACTICS registry) |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2023/01/26 12:03:39 |
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Basic information
Public title
Tokyo / Kanagawa / Chiba / Shizuoka / Ibaraki active OCT applications for ACS (TACTICS registry)
Acronym
TACTICS registry
Scientific Title
Tokyo / Kanagawa / Chiba / Shizuoka / Ibaraki active OCT applications for ACS (TACTICS registry)
Scientific Title:Acronym
TACTICS registry
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome (ACS)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the etiology of acute coronary syndrome in Japan using OCT and investigate its relationship to prognosis.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between non-culprit plaque and clinical events.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Evaluation of culprit lesion of ACS using OCT
1. Plaque rupture
2. Plaque erosion
3. Calcified nodule
4. Spontaneous coronary artery dissection
5. Others
6. Undecidable
Key secondary outcomes
1.OCT evaluation
2.Angiographic endpoints
3.clinical events
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
Inclusion Criteria
1) Patient who perform primary PCI for acute coronary syndrome (unstable angina and acute myocardial infarction)
2) ACS patients who underwent primary PCI using optical coherence tomography.
3) All patients or proxies receive from physicians the information necessary to give informed consent in writing.
4) Patients aged more than 20 years old.
Key exclusion criteria
Exclusion Criteria
1) Patient with limited life expectancy<2 years
2) Patients who can not continue DAPT of aspirin and P2Y12 receptor antagonist.
3) Planned surgery within 3 months.
4) Pregnant or possibility of pregnancy.
5) ACS at a lesion where a stent has already been implanted.
6) Patients unsuitable for OCT-guided PCI.
7) Patient with a history of side effects from aspirin, clopidogrel, or prasugrel.
8) Patients who are difficult to receive 12 months follow-up after primary PCI.
9) Patients judged inappropriate for this study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Shinke |
Organization
Showa University
Division name
Division of Cardiology
Zip code
142-8666
Address
1-5-8, Hatanodai Shinagawa-ku, Tokyo
TEL
03-3784-8539
shinke@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Mizukami |
Organization
TACTICS Study Secretariat
Division name
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Zip code
157-8577
Address
6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo
TEL
03-3300-5247
Homepage URL
tactics@ofc.showa-u.ac.jp
Sponsor or person
Institute
Showa University Division of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Abbott Medical Japan LLC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Certified Review Board
Address
1-5-8, Hatanodai Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-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
昭和大学病院、昭和大学藤が丘病院、昭和大学横浜市北部病院、昭和大学江東豊洲病院、江戸川病院、NTT東日本関東病院、亀田総合病院、関東労災病院、菊名記念病院、榊原記念病院、順天堂大学病院、順天堂大学静岡病院、新東京病院、聖マリアンナ医科大学、帝京大学医学部附属病院、東海大学医学部付属病院、東京医科歯科大学、東京医科大学病院、東京女子医科大学、東京大学医学部附属病院、日本医大千葉北総病院、ひたち医療センター、武蔵野赤十字病院、横浜栄共済病院、横浜市立大学病院付属市民病院医療センター、横浜南共済病院、綾瀬循環器病院、土浦協同病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
702
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 | 11 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow up on each patients for 24 months after Primary PCI procedure.
Management information
Registered date
| 2020 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044503
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| Registered date | File name |
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| Registered date | File name |
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