Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients
OPERA
1 other identifier
interventional
1,187
1 country
112
Brief Summary
A prospective multicenter registry in real-world Japanese patients undergoing DAPT for three months after stenting. To assess the long-term safety of Endeavor Zotarolimus-eluting stent through noninferiority in the primary endpoint between two different continuous regimen (three and twelve months) groups of DAPT after stenting with Endeavor Zotarolimus-eluting stent in real-world Japanese patients and to examine the optimal duration of DAPT after stenting with Endeavor Zotarolimus-eluting stent. The long-term DAPT group in the present clinical study (to be appropriated from the post-marketing surveillance of Endeavor) should consist of consecutive patients undergoing DAPT for twelve months after stenting, while the short-term DAPT group (to be newly registered in the present clinical study) should consist of patients who are instructed to undergo DAPT for three months after stenting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Apr 2011
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 7, 2016
January 1, 2016
2.4 years
March 29, 2011
January 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NACCE (Net adverse clinical and cerebral event)
NACCE is defined as a composite endpoint consisting of death from some causes (including cardiac death and noncardiac death), myocardial infarction (Q-wave MI and non-Q wave MI), cerebral vascular accident, and major bleeding (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding).
12 months
Secondary Outcomes (6)
Stent thrombosis
12 months
MACE (major adverse cardiac events)
1, 3, 6, 9 and 12 months
TVR (target vessel revascularization)
9 and 12 months
TLR (target lesion revascularization)
9 and 12 months
DAPT compliance
12 months
- +1 more secondary outcomes
Study Arms (2)
Short-term DAPT group
EXPERIMENTAL1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and clopidogrel)
Long-term DAPT group
NO INTERVENTION1,200 patients to be appropriated from E-Japan post-marketing surveillance who meet all inclusion criteria and do not fall under any exclusion criteria of the present clinical study: Undergo 12-month DAPT (aspirin and clopidogrel)
Interventions
DAPT using aspirin 81 mg/day (minimal dose) and clopidogrel 75 mg/day should be conducted for 3 months (+ 30 days) after stenting.
Eligibility Criteria
You may qualify if:
- Patient over age 20 years.
- Patient who is clinically indicated for PCI by stenting at least in one coronary lesion that is visually confirmed by coronary angiography.
- Patient who has agreed to conditions after receiving an explanation about the contents of the present clinical study and who has signed the consent form approved by the ethical review board at each study site.
- Patient who has agreed to undergo all clinical FUs listed in the present protocol.
- Patient who has a \> 50% occlusion or stenosis that is visually confirmed by coronary angiography in a native coronary artery \> 2.5 mm in diameter and in whom the relevant coronary artery has an anatomical structure that is eligible for PCI with Endeavor Zotarolimus-eluting stent.
You may not qualify if:
- Patient over age 85 years.
- Patient with cardiogenic shock.
- Patient who underwent stent treatment with BMS in other lesions within 6 months prior to the conduct of index PCI of the target vessel.
- Patient who has undergone some treatment with DES for coronary lesions.
- Patient who is scheduled to undergo elective surgery within 12 months after index PCI.
- Patient whose left ventricular ejection fraction (LVEF) is \< 40%.
- Patient with a hemorrhagic predisposition or a history of coagulation abnormality
- Patient in whom the total number of deployed stents exceeds 4,regardless of the number of lesions and the number of affected branches.
- Patient with a verified history of CVA before stenting.
- Patient with a verified history of active peptic ulcer or upper gastrointestinal tract bleeding before Stenting.
- Patient showing impaired renal function. (serum creatinine concentration: \> 1.8 mg/dL)
- Patient with known contraindications for aspirin or clopidogrel. (the physician should assess tolerability within the range of routine medical care)
- Patient with a known disorder who has a life expectancy of less than 12 months.
- Patient who is incompetent to adhere to all clinical FUs listed in the present protocol.
- Lesions located within the saphenous venin graft (SVG).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
Asahi General Hospital
Asahi, Chiba, Japan
Kimitsu Chuo Hospital
Kisarazu, Chiba, Japan
Fukui Cardiovascular Center
Fukui-shi, Fukui, Japan
Fukuoka City Hospital
Fukuoka, Fukuoka, Japan
Fukuoka City Medical Association Hospital
Fukuoka, Fukuoka, Japan
Fukuoka Red Cross Hospital
Fukuoka, Fukuoka, Japan
University of Occupational and Environmental Health
Kita-Kyushu City, Fukuoka, Japan
National Hospital Organization Fukuoka-Higashi Medical Center
Koga, Fukuoka, Japan
Gifu Heart Center
Gifu, Gifu, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan
Hiroshima Railway Hospital
Hiroshima, Hiroshima, Japan
Tsuchiya General Hospital
Hiroshima, Hiroshima, Japan
Engaru-Kosei General Hospital
Monbetsu-gun, Hokkaido, Japan
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyōgo, Japan
Kansai Rosai Hospital, Cardiovascular Center
Amagasaki, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Shakaihoken Kobe Central Hospital
Kobe, Hyōgo, Japan
Miki City Hospital
Miki, Hyōgo, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
Meiwa General Hospital
Nishinomiya, Hyōgo, Japan
Hyogo Prefectural Awaji Hospital
Sumoto, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kaisei General Hospital
Sakaidechō, Kagawa-ken, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Tenyoukai Central Hospital
Kagoshima, Kagoshima-ken, Japan
Ebina General Hospital
Ebina, Kanagawa, Japan
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan
Kawasaki Municipal Tama Hospital
Kawasaki, Kanagawa, Japan
St. Marianna University of Medicine, Toyoko Hospital
Kawasaki, Kanagawa, Japan
St. Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
Synthesis Shinkawahashi Hospital
Kawasaki, Kanagawa, Japan
Odawara Cardiovascular Hospital
Odawara, Kanagawa, Japan
Kitazato University School of Medicine
Sagamihara, Kanagawa, Japan
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, Japan
Kanagawa Cardiovascular and Reppiratory Center
Yokohama, Kanagawa, Japan
Saiseikai Yokohama Tobu Hospital
Yokohama, Kanagawa, Japan
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, Japan
St. Marianna University of Medicine, Yokohama City West Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokohama City UNiversity Medical Center
Yokohama, Kanagawa, Japan
Kumamoto Chuo Hospital
Kumamoto, Kumamoto, Japan
Kumamoto Red Cross Hospital
Kumamoto, Kumamoto, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Sugimura Hospital
Kumamoto, Kumamoto, Japan
Ijinkai Takeda General Hospital
Kyoto, Kyoto, Japan
Koseikai Takeda Hospital
Kyoto, Kyoto, Japan
Kyoto Second Red Cross Hospital
Kyoto, Kyoto, Japan
Gakken The Holy City Medical Association Hospital
Sagara-gun, Kyoto, Japan
Uji Tokushukai Hospital
Uji, Kyoto, Japan
Matsuzaka Central General Hospital
Matsuzaka City, Mie-ken, Japan
Suzuka Central General Hospital
Suzuka, Mie-ken, Japan
Mie Heart Center
Taki-gun, Mie-ken, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Nagasaki University Graduate School of Biomedical Science
Nagasaki, Nagasaki, Japan
Kawasaki Medical School
Kurashiki, Okayama-ken, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan
The Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, Japan
Ohama Daiichi Hospital
Naha, Okinawa, Japan
Nakagami Hospital
Okinawa, Okinawa, Japan
Okinawa Nanbu Tokushukai Hospital
Shimajiri-gun, Okinawa, Japan
Urasoe General Hospital
Urasoe, Okinawa, Japan
Kawachi General Hospital
Higashiosaka, Osaka, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Kansai Medical University Takii Hospital
Moriguchi, Osaka, Japan
Komatsu General Hospital
Neyagawa, Osaka, Japan
Higashi-sumiyoshi Morimoto Hospital
Osaka, Osaka, Japan
Nissay Hospital
Osaka, Osaka, Japan
Osaka City General Hospital
Osaka, Osaka, Japan
Osaka City University, Graduate School of Medicine
Osaka, Osaka, Japan
Osaka Ekisaikai Hospital
Osaka, Osaka, Japan
Osaka General Hospital of West Japan Railway Campany
Osaka, Osaka, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Osaka Gyoumeikan Hospital
Osaka, Osaka, Japan
Osaka Police Hospital
Osaka, Osaka, Japan
Sakurabashi Watanabe Hospital
Osaka, Osaka, Japan
Bell Land General Hospital
Sakai, Osaka, Japan
Mimihara General Hospital
Sakai, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Osaka University Graduate School of Medicine
Suita, Osaka, Japan
Saiseikai Senri Hospital
Suita, Osaka, Japan
Hokusetsu General Hospital
Takatsuki, Osaka, Japan
Midorigaoka Hospital
Takatsuki, Osaka, Japan
Department of Cardiovascular Medicine, Saga University
Saga, Saga-ken, Japan
Mashiko Hospital
Kawaguchi, Saitama, Japan
Saitama Medical Center, Jichi Medical University
Saitama, Saitama, Japan
Kusatsu Heart Center
Kusatsu, Shiga, Japan
Shiga Medical Center for Adults
Moriyama, Shiga, Japan
Omihachiman Community Medical Center
Ōmihachiman, Shiga, Japan
Biwako Ohashi Hospital
Ōtsu, Shiga, Japan
Hamamatsu Medical Center
Hamamatsu, Shizuoka, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Tokushima Red Cross Hospital
Komatsushimachō, Tokushima, Japan
Ayase Heart Hospital
Adachi-ku, Tokyo, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
Sakakibara Heart Institute
Fuchū, Tokyo, Japan
Tokyo Metroporitan Tama Medical Center
Fuchū, Tokyo, Japan
Itabashi Chuo Medical Center
Itabashi-ku, Tokyo, Japan
Nihon University School of Medicine
Itabashi-ku, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Tokyo Metroporitan Geriatric Hospital and Institute of Gerontology
Itabashi-ku, Tokyo, Japan
Toho University Medical Center Ohashi Hospital
Meguro-ku, Tokyo, Japan
The Cardiovascular Institute
Minato-ku, Tokyo, Japan
The Jikei University Hospital
Minato-ku, Tokyo, Japan
JR Tokyo General Hospital
Shibuya-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Tottri University
Yonago, Tottri, Japan
Shuto General Hospital
Yanai, Yamaguchi, Japan
Non-profit organization Associations for Establishiment of Evidence in Interventions
Minato-ku, Tokyo, 105-0013, Japan
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Takaaki Isshiki, M.D.
Teikyo University
- PRINCIPAL INVESTIGATOR
Shinsuke Nanto, M.D.
Osaka University
- PRINCIPAL INVESTIGATOR
Masato Nakamura, M.D.
Toho University Ohashi Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2011
First Posted
March 30, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2013
Study Completion
December 1, 2013
Last Updated
January 7, 2016
Record last verified: 2016-01