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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019948
Receipt No. R000022290
Scientific Title ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study
Date of disclosure of the study information 2015/11/27
Last modified on 2017/12/05

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Basic information
Public title ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study
Acronym ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study(STOPDAPT-2)
Scientific Title ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study
Scientific Title:Acronym ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study(STOPDAPT-2)
Region
Japan

Condition
Condition Coronary Heart Disease, Angina Pectoris, Myocardial Infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

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).
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 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 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
Last 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-Kawara Cho, Sakyo-ku, KYOTO
TEL 075-751-4254
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hirotoshi Watanabe
Organization Kyoto University, Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02619760
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 <北海道>手稲渓仁会病院(廣上貢),札幌医大病院(三浦哲嗣),北光記念病院(野崎洋一),千歳市民病院(池田大輔),<青森県>弘前大学病院(富田泰史),<岩手県>岩手医大病院(森野禎浩),岩手県立中部病院(齊藤秀典),<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),東北医薬大病院(片平美明),<秋田県>中通総合病院(佐藤誠),<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),太田西ノ内病院(小松宣夫),<栃木県>自治医大病院(苅尾七臣),<埼玉県>益子病院(清水昭吾),国立埼玉病院(松村圭祐),<千葉県>千葉徳洲会病院(上田修),君津中央病院(山本雅史),<東京都>三井記念病院(田邉健吾),聖路加国際病院(三橋弘嗣),順天堂大学順天堂医院(代田浩之),東京医科歯科大病院(足利貴志),日本医大病院(清水渉),同愛記念病院(高橋保裕),江戸川病院(大平洋司),昭和大江東豊洲病院(若林公平),慶應義塾大学病院(前川裕一郎),東京医科大病院(山下淳),東京女子医大病院(萩原誠久),総合東京病院(村松俊哉),豊島病院(畑明宏),帝京大学病院(興野寛幸),板橋中央総合病院(太田洋),順大練馬病院(藤原康昌),杏林大学病院(高昌秀安),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),河北総合病院(登坂淳),<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),済生会横浜市東部病院(伊藤良明),横浜市立みなと赤十字病院(沖重薫),横浜市大市民総合医療センター(木村一雄),横浜医療センター(森文章),横浜栄共済病院(道下一朗),北里大学病院(阿古潤哉),平塚共済病院(大西祐子),東海大学病院(伊苅裕二),<石川県>金沢循環器病院(名村正伸),石川県立中央病院(松原隆夫),金沢医療センター(阪上学),<福井県>福井循環器病院(水野清雄),福井大学病院(宇随弘泰),市立敦賀病院(音羽勘一),<山梨県>山梨大学病院(尾畑純栄),<長野県>信州大学病院(海老澤聡一朗),<岐阜県>岐阜県総合医療センター(野田俊之),大垣市民病院(坪井英之),<静岡県>順天堂大学静岡病院(諏訪哲),静岡医療センター(田邊潤),静岡県立総合病院(坂本裕樹),静岡市立静岡病院(小野寺知哉),浜松医科大学病院(佐藤洋),浜松医療センター(小林正和),<愛知県>名古屋第二赤十字病院(七里守),藤田保健衛生大学病院(尾崎行男),市立半田病院(榊原雅樹),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),三重大学病院(伊藤正明),永井病院(星野康三),三重ハートセンター(西川英郎),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),滋賀県立成人病センター(池口滋),<京都府>京都大学病院(木村剛),京都医療センター(赤尾昌治),三菱京都病院(横松考史),<大阪府>北野病院(猪子森明),大阪赤十字病院(稲田司),国立循環器病研究センター(安田聡),大阪医科大学病院(石坂信和),近畿大学病院(宮崎俊一),耳原総合病院(石原昭三),大阪労災病院(西野雅巳),ベルランド総合病院(片岡亨),大阪市立総合医療センター(成子隆彦),<兵庫県>神戸大学病院(新家俊郎),神戸市立医療センター中央市民病院(木下愼),関西労災病院(真野敏昭),<奈良県>近畿大奈良病院(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),和歌山県立医大病院 (赤阪隆史),<島根県>島根大学病院(田邊一明),島根県立中央病院(小田強),<岡山県>岡山大学病院(吉田雅言),岡山赤十字病院(佐藤哲也),倉敷中央病院(門田一繁),<広島県>広島大学病院(木原康樹),<山口県>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),<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),愛媛大学病院(檜垣實男),<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),福岡和白病院(芹川威),福岡徳洲会病院(下村英紀),<熊本県>熊本大学病院(辻田賢一),済生会熊本病院(坂本知浩),熊本赤十字病院(角田隆輔),熊本中央病院(野田勝生),<宮崎県>県立延岡病院(山本展誉),<鹿児島県>指宿医療センター(鹿島克郎),天陽会中央病院(高岡順一郎),鹿児島医療センター(中島均),出水郡医師会広域医療センター(吉野聡史),<沖縄県>浦添総合病院(上原裕規),中頭病院(石盛博) ※()内は各施設責任者

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 27 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 No longer recruiting
Date of protocol fixation
2015 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 25 Day
Last follow-up date
2022 Year 12 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2023 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 27 Day
Last modified on
2017 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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