UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029981 |
|---|---|
| Receipt number | R000034230 |
| Scientific Title | The study to evaluate ShorT and OPtimal duration of Dual AntiPlatelet Therapy for the patients with ACS |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2022/05/19 22:11:37 |
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Basic information
Public title
The study to evaluate ShorT and OPtimal duration of Dual AntiPlatelet Therapy for the patients with ACS
Acronym
The study to evaluate ShorT and OPtimal duration of Dual AntiPlatelet Therapy for the patients with ACS (STOPDAPT-2 ACS)
Scientific Title
The study to evaluate ShorT and OPtimal duration of Dual AntiPlatelet Therapy for the patients with ACS
Scientific Title:Acronym
The study to evaluate ShorT and OPtimal duration of Dual AntiPlatelet Therapy for the patients with ACS (STOPDAPT-2 ACS)
Region
| Japan |
Condition
Condition
Coronary Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety of reducing DAPT duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES) for the patients with acute coronary syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The composite of cardiovascular death, myocardial infarction (MI), stroke (ischemic and hemorrhagic), stent thrombosis (Definite stent thrombosis yet to develop into MI), and severe bleeding (TIMI Major/Minor) at 12 months after index PCI.
Key secondary outcomes
Cardiovascular death, MI, Stroke, ARC definite ST, Major bleeding (TIMI Major/ Minor) at 12 months after index PCI.
Cardiovascular death, MI, Stroke, ARC definite ST, Major bleeding (TIMI Major/ Minor), Upper gastrointestinal endoscopy / upper gastrointestinal endoscopic treatment
at 60 months after index PCI.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After PCI for the ACS patients with Xience, dual antiplatelet therapy (DAPT) will be performed for one month. Following that, clopidogrel monotherapy will be continued up to 5 years after index PCI (1-month DAPT group)
Interventions/Control_2
After PCI for the ACS patients with Xience, dual antiplatelet therapy (DAPT) will be performed for twelve months. Following that, aspirin monotherapy will be continued up to 5 years after index PCI (12-month DAPT group)
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
1. Patients who have undergone PCI with the everolimus-eluting cobalt-chromium stent (EES, XienceTM)
2. Patients who have not experienced major complications (death, MI, stroke, or major bleeding) during hospital stay for treatment
3. Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist
Key exclusion criteria
1. Patients requiring oral anticoagulants
2. Patients with medical history of intracranial hemorrhage
3. Patients who have experienced serious complications (MI, stroke, and major bleeding) during hospital stay post-PCI
4. Patients with DES other than Xience implanted in PCI performed at the time of enrollment
5. Patients confirmed to have no tolerability to clopidogrel before enrollment
6. Patients requiring continuous administration of antiplatelet drugs (PDE3 inhibitors, prostaglandin preparations, etc.) other than aspirin and P2Y12 receptor inhibitors (prasugrel, clopidogrel, and ticlopidine) at the time of enrollment
7. Patients with coronary bioabsorbable vascular scaffold (BVS) implanted prior to or at the time of enrollment
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54, Shogoin-Kawara Cho, Sakyo-ku, Kyoto
TEL
075-751-4254
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54, Shogoin-Kawara Cho, Sakyo-ku, Kyoto
TEL
075-751-4255
Homepage URL
hwatanab@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Abbott Vascular Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Institute for Production Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Certified Review Board
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT03462498
Org. issuing International ID_1
the U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
2022年2月現在、下記施設が参加（カッコ内は各施設責任者）。<北海道>手稲渓仁会病院(廣上貢),北晨会恵み野病院（牧口展子）,北光記念病院(野崎洋一),<青森県>弘前大学医学部附属病院(富田泰史),<岩手県>岩手医科大学附属病院(森野禎浩),<宮城県>仙台厚生病院(伊澤毅),仙台循環器病センター(八木勝宏),東北医科薬科大学病院(小丸達也),<茨城県>水戸済生会総合病院（樋口基明）,<埼玉県>かわぐち心臓呼吸器病院(徳山榮男),上尾中央総合病院(一色高明),<東京都>三井記念病院(田邉健吾),虎の門病院(児玉隆秀),昭和大学江東豊洲病院(若林公平),河北総合病院(登坂淳),榊原記念病院(高見澤格),多摩総合医療センター(田中博之),みなみ野循環器病院(幡芳樹),東大和病院(加藤隆一),<神奈川県>聖マリアンナ医科大学病院(明石嘉浩),横浜労災病院(柚本和彦),昭和大学藤が丘病院(鈴木洋),横浜市大附属市民総合医療センター(日比潔),藤沢市民病院(塚原健吾),北里大学病院(阿古潤哉),平塚共済病院(大西祐子),東海大学医学部付属病院(伊苅裕二),<福井県>福井大学医学部附属病院(宇隨弘泰),<岐阜県>岐阜県総合医療センター(野田俊之),大垣市民病院(森島逸郎),<静岡県>順天堂大学医学部附属静岡病院(諏訪哲),静岡県立総合病院(坂本裕樹),静岡済生会総合病院（山田実）,<愛知県>日本赤十字社愛知医療センター名古屋第二病院(吉田路加),市立半田病院(鈴木進),一宮西病院(前田拓哉),<三重県>松阪中央総合病院 (谷川高士),<滋賀県>大津赤十字病院(貝谷和昭),<京都府>京都大学医学部附属病院(尾野亘),宇治徳洲会病院(松岡俊三),国立病院機構京都医療センター(赤尾昌治),三菱京都病院(横松孝史),<大阪府>北野病院(猪子森明),大阪赤十字病院(稲田司),大阪急性期・総合医療センター(森田孝),近畿大学病院(中澤学),耳原総合病院(石原昭三),<兵庫県>神戸市立医療センター中央市民病院(木下愼),ツカザキ病院(楠山貴教),<奈良県>近畿大学奈良病院(東儀圭則),天理よろづ相談所病院(田村俊寛),<和歌山県>日本赤十字社和歌山医療センター(渡辺大基),和歌山県立医科大学附属病院 (田中篤),<岡山県>岡山医療センター(田渕勲),倉敷中央病院(門田一繁),<広島県>広島大学病院(中野由紀子),県立広島病院(上田浩徳),<山口県>国立病院機構岩国医療センター(片山祐介),徳山中央病院(分山隆敏),下関市立市民病院(金子武生),<徳島県>徳島大学病院(若槻哲三),徳島赤十字病院(岸宏一),<香川県>香川県立中央病院(土井正行),<愛媛県>愛媛県立中央病院(岡山英樹),<高知県>近森病院(川井和哉),<福岡県>小倉記念病院(安藤献児),済生会福岡総合病院(末松延裕),飯塚病院(井上修二朗),<佐賀県>佐賀大学医学部附属病院(夏秋政浩),<熊本県>熊本大学病院(辻田賢一),済生会熊本病院(坂本知浩),人吉医療センター(黒川博文),<鹿児島県>国立病院機構指宿医療センター(鹿島克郎),<沖縄県>浦添総合病院(上原裕規)
全74施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://jamanetwork.com/journals/jamacardiology/fullarticle/2789701
Number of participants that the trial has enrolled
3008
Results
In the pooled 4136 patients, 2058 were assigned into the 1-month DAPT group and 2078 were assigned into the 12-month DAPT group. The 1-year incidence rate of the primary end point comprising cardiovascular and bleeding events was 3.2% in those in the 1-month DAPT group and 2.8% in the 12-month DAPT group, which did not meet the noninferiority of the 1-month DAPT group.
Results date posted
| 2022 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 02 | Day |
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
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034230
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