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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029981
Receipt No. 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 2019/05/19

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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
Email 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
Email hwatanab@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department

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
Email 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 平成30年4月現在、下記施設の参加予定(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),旭川厚生病院(鈴木孝英),<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(大友達志),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),<秋田県>中通総合病院(阪本亮平),<山形県>日本海総合病院(菅原重生),<福島県>星総合病院(清野義胤),<茨城県>水戸済生会総合病院(樋口基明),<栃木県>自治医科大学附属病院(苅尾七臣),<埼玉県>かわぐち心臓呼吸器病院(徳山榮男),益子病院(清水昭吾),上尾中央総合病院(一色高明),<千葉県>東京ベイ・浦安市川医療センター(小船井光太郎),順天堂大学医学部附属浦安病院(横山健),君津中央病院(山本雅史),<東京都>三井記念病院(田邉健吾),虎の門病院(児玉隆秀),綾瀬循環器病院(高瀬哲郎),同愛記念病院(高橋保裕),昭和大学江東豊洲病院(若林公平),東京女子医科大学病院(萩原誠久),総合東京病院(村松俊哉),河北総合病院(登坂淳),順天堂大学医学部附属練馬病院(横山健),榊原記念病院(桃原哲也),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),菊名記念病院(本江純子),横浜労災病院(柚本和彦),昭和大学藤が丘病院(鈴木洋),済生会横浜市東部病院(伊藤良明),横浜市大附属市民総合医療センター(木村一雄),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),<石川県>金沢循環器病院(名村正伸),<福井県>福井大学医学部附属病院(宇随弘泰),市立敦賀病院(音羽勘一),<山梨県>山梨大学医学部附属病院(尾畑純栄),<長野県>信州大学医学部附属病院(海老澤聡一朗),<岐阜県>岐阜県総合医療センター(岩間眞),大垣市民病院(高木健督),<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>名古屋第二赤十字病院(七里守),市立半田病院(神野泰),公立陶生病院(浅野博),一宮西病院(寺本智彦),<三重県>四日市羽津医療センター(川村正樹),松阪中央総合病院 (谷川高士),名張市立病院(片岡一明),<滋賀県>大津赤十字病院(貝谷和昭),彦根市立病院(中野顕),<京都府>康生会武田病院(中村玲雄),京都府立医科大学附属病院(全完),京都大学医学部附属病院(木村剛),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),国立循環器病研究センター(安田聡),近畿大学医学部附属病院(宮崎俊一),耳原総合病院(石原昭三),ベルランド総合病院(片岡亨),<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>近畿大学医学部奈良病院(城谷学),天理よろづ相談所病院(中川義久),<和歌山県>日本赤十字社和歌山医療センター(田村崇),和歌山県立医科大学附属病院 (赤阪隆史),<島根県>島根大学医学部附属病院(田邊一明),<岡山県>岡山赤十字病院(佐藤哲也),岡山医療センター(宗政充),津山中央病院(柚木佳),倉敷中央病院(門田一繁),<広島県>広島大学病院(木原康樹),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(櫻木悟),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),三豊総合病院(高石篤志),<愛媛県>愛媛県立中央病院(岡山英樹),松山赤十字病院(盛重邦雄),<高知県>近森病院(川井和哉),<福岡県>小倉記念病院(安藤献児),産業医科大学病院(園田信成),済生会福岡総合病院(末松延裕),福岡徳洲会病院(下村英紀),飯塚病院(堤孝樹),<佐賀県>佐賀大学医学部附属病院(夏秋政浩),<熊本県>熊本大学医学部附属病院(辻田賢一),済生会熊本病院(坂本知浩),熊本赤十字病院(池本智一),人吉医療センター(中村伸一),<宮崎県>県立延岡病院(山本展誉),<鹿児島県>国立病院機構指宿医療センター(鹿島克郎),出水郡医師会広域医療センター(安﨑和博),<沖縄県>浦添総合病院(上原裕規),全112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
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 Open public 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
2019 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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