UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019948 |
|---|---|
| Receipt number | 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 | 2024/06/03 12:16:58 |
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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
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
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
2021年11月現在下記施設、（）内は責任医師<北海道>手稲渓仁会病院(廣上貢),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)<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)<栃木県>自治医科大学附属病院(苅尾七臣)<埼玉県>益子病院(清水昭吾)<千葉県>君津中央病院(山本雅史)<東京都>三井記念病院(田邉健吾),順天堂大学医学部附属順天堂医院(代田浩之),同愛記念病院(高橋保裕),江戸川病院(大平洋司),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(中野雅嗣),順天堂大学医学部附属練馬病院(田村浩),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),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),横浜市大附属市民総合医療センター(日比潔),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)<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)<愛知県>名古屋第二赤十字病院(吉田路加),市立半田病院(鈴木進),公立陶生病院(浅野博),一宮西病院(前田拓哉)<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(武内哲史郎)<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>京都大学医学部附属病院(木村剛),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),国立循環器病研究センター(野口暉夫),近畿大学医学部附属病院(中澤学),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)<奈良県>近畿大学医学部奈良病院(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)<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(福家聡一郎),倉敷中央病院(門田一繁)<広島県>広島大学病院(中野由紀子)<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),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)<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)<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(小瀬戸一平)<沖縄県>浦添総合病院(上原裕規),中頭病院(石盛博),全90施設
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
https://jamanetwork.com/journals/jama/fullarticle/2736563
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jama/fullarticle/2736563
Number of participants that the trial has enrolled
3045
Results
3009 were included in the analysis and assigned to 1500 participants in the 1-month DAPT group and 1509 participants in the 12-month DAPT group. The primary endpoint (composite of cardiovascular death, myocardial infarction, stent thrombosis [ARC definite], stroke, and bleeding [TIMI definition major/minor]) was 2.36% in the 1-month DAPT group and 3.70% in the 12-month DAPT group, with a HR of 0.64 (95% CI 0.42-0.98), indicating non-inferiority (p<0.001) and superiority (p=0.04).
Results date posted
| 2020 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 06 | Month | 25 | Day |
Baseline Characteristics
The study population reflected a typical Japanese PCI population, including patients with advanced age (mean, 68.6 years), male sex (78%), diabetes (39%), stable coronary artery disease (62%), and acute coronary syndrome (38%). The majority of patients had low or intermediate thrombotic and bleeding risks based on both the CREDO-Kyoto risk score (92% and 93%, respectively) and the PARIS risk score (86% and 80%, respectively).28,29 Angiographic and procedural characteristics also reflected typical Japanese PCI practice, with predominance of the radial approach and intracoronary imaging guidance. The median SYNTAX score was 9 (categorized as low for coronary anatomic complexity) among 589 patients randomly selected for core laboratory assessment. Regarding medications at discharge, statins were prescribed in 88% of patients and beta-blockers in 44%. Proton pump inhibitors were prescribed in 79% of patients. Baseline characteristics and medications were well balanced between the 2 groups. Data were missing for prior first-generation drug-eluting stents in 2 patients, for prior MI in 1 patient, for anemia in 6 patients, for severe chronic kidney disease in 10 patients, for thrombocytopenia in 11 patients, and for left ventricular ejection fraction in 246 patients.
Participant flow
From December 25, 2015, to December 8, 2017, among 6504 patients eligible for the study, 3045 patients were randomized at 90 centers in Japan; 3459 eligible patients were not enrolled in the study, mainly because of judgment of attending physician or patient refusal. Excluding 36 patients who withdrew consent, 3009 patients were included in the main analysis: 1500 patients in the 1-month DAPT group and 1509 patients in the 12-month DAPT group. Randomization was performed a median of 1 day (interquartile range, 0-4 days) after the index PCI.
Adverse events
The adverse events that did occur were predictable in post-PCI patients, and no adverse events specific to this study occurred.
Outcome measures
Final 1-year clinical follow-up was completed in January 2019. Complete 1-year clinical follow-up was achieved in 2974 patients (98.8%) (Figure 1). The primary end point occurred in 35 patients (2.36%) in the 1-month DAPT group and in 55 patients (3.70%) in the 12-month DAPT group. One month of DAPT met criteria for noninferiority and also met criteria for superiority to 12 months of DAPT for the primary end point.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 25 | Day |
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
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022290
