Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients
- Registration Number
- NCT01325935
- Lead Sponsor
- Associations for Establishment of Evidence in Interventions
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1187
-
Clinical inclusion criteria
- 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.
-
Coronary angiographic inclusion criteria:
- 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.
-
Clinical exclusion criteria
- Patient over age 85 years.
- Patient with ST elevation MI who requires primary or rescue PCI and whose performance status falls under any of the exclusion criteria.
- 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.
-
Angiographic exclusion criteria:
- Lesions located within the saphenous venin graft (SVG).
- Unprotected lesions in the left coronary trunk.
- Lesions of in-stent restenosis in previously deployed DES or BMS.
- Lesions with an anatomical structure of the coronary artery that is not eligible for treatment by the deployment of Endeavor ZES.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Short-term DAPT group Clopidogrel 1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and clopidogrel)
- Primary Outcome Measures
Name Time Method NACCE (Net adverse clinical and cerebral event) 12 months 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).
- Secondary Outcome Measures
Name Time Method Stent thrombosis 12 months Incidence of stent thrombosis as per the definition by academic research council
MACE (major adverse cardiac events) 1, 3, 6, 9 and 12 months Incidence of MACE at months 1, 3, 6, 9, and 12 after stenting. MACE is defined as a composite endpoint consisting of cardiac death from some causes (including cardiac and noncardiac death), MI (Q-wave MI and non-Q wave MI), TLR, and coronary artery bypass graft (CABG).
TVR (target vessel revascularization) 9 and 12 months Incidence of target vessel revascularization at months 9 and 12 after stenting.
DAPT compliance 12 months Duration of DAPT and patient compliance.
TLR (target lesion revascularization) 9 and 12 months Incidence of target lesion revascularization at months 9 and 12 after stenting.
Hemorrhagic complications 12 months Incidence of hemorrhagic complications. (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding)
Trial Locations
- Locations (112)
Kimitsu Chuo Hospital
🇯🇵Kisarazu City, Chiba, Japan
Fukui Cardiovascular Center
🇯🇵Fukui City, Fukui, Japan
Fukuoka City Medical Association Hospital
🇯🇵Fukuoka City, Fukuoka, Japan
Fukuoka Red Cross Hospital
🇯🇵Fukuoka City, Fukuoka, Japan
University of Occupational and Environmental Health
🇯🇵Kita-Kyushu City, Fukuoka, Japan
National Hospital Organization Fukuoka-Higashi Medical Center
🇯🇵Koga City, Fukuoka, Japan
Tsuchiya General Hospital
🇯🇵Hiroshima City, Hiroshima, Japan
Fukuyama City Hospital
🇯🇵Fukuyama City, Hiroshima, Japan
Gifu Heart Center
🇯🇵Gifu City, Gifu, Japan
Hyogo Prefectural Amagasaki Hospital
🇯🇵Amagasaki City, Hyogo, Japan
Miki City Hospital
🇯🇵Miki City, Hyogo, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe City, Hyogo, Japan
Meiwa General Hospital
🇯🇵Nishinomiya City, Hyogo, Japan
Shakaihoken Kobe Central Hospital
🇯🇵Kobe City, Hyogo, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya City, Hyogo, Japan
Tenyoukai Central Hospital
🇯🇵Kagoshima City, Kagoshima, Japan
Hyogo Prefectural Awaji Hospital
🇯🇵Sumoto City, Hyogo, Japan
Kanazawa University Hospital
🇯🇵Kanazawa City, Ishikawa, Japan
Kaisei General Hospital
🇯🇵Sakaide City, Kagawa, Japan
Kagoshima University Hospital
🇯🇵Kagoshima City, Kagoshima, Japan
Fujisawa City Hospital
🇯🇵Fujisawa City, Kanagawa, Japan
Ebina General Hospital
🇯🇵Ebina City, Kanagawa, Japan
Kawasaki Municipal Tama Hospital
🇯🇵Kawasaki City, Kanagawa, Japan
St. Marianna University of Medicine, Toyoko Hospital
🇯🇵Kawasaki City, Kanagawa, Japan
St. Marianna University School of Medicine
🇯🇵Kawasaki City, Kanagawa, Japan
Odawara Cardiovascular Hospital
🇯🇵Odawara City, Kanagawa, Japan
Synthesis Shinkawahashi Hospital
🇯🇵Kawasaki City, Kanagawa, Japan
Kitazato University School of Medicine
🇯🇵Sagamihara City, Kanagawa, Japan
Saiseikai Yokohama Tobu Hospital
🇯🇵Yokohama City, Kanagawa, Japan
Showa University Fujigaoka Hospital
🇯🇵Yokohama City, Kanagawa, Japan
St. Marianna University of Medicine, Yokohama City West Hospital
🇯🇵Yokohama City, Kanagawa, Japan
Kumamoto Red Cross Hospital
🇯🇵Kumamoto City, Kumamoto, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto City, Kumamoto, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto City, Kumamoto, Japan
Ijinkai Takeda General Hospital
🇯🇵Kyoto City, Kyoto, Japan
Koseikai Takeda Hospital
🇯🇵Kyoto City, Kyoto, Japan
Kyoto Second Red Cross Hospital
🇯🇵Kyoto City, Kyoto, Japan
Gakken The Holy City Medical Association Hospital
🇯🇵Sagara-gun, Kyoto, Japan
Suzuka Central General Hospital
🇯🇵Suzuka City, Mie, Japan
Uji Tokushukai Hospital
🇯🇵Uji City, Kyoto, Japan
Mie Heart Center
🇯🇵Taki-gun, Mie, Japan
Mie University Hospital
🇯🇵Tsu City, Mie, Japan
Nagasaki University Graduate School of Biomedical Science
🇯🇵Nagasaki City, Nagasaki, Japan
Kawasaki Medical School
🇯🇵Kurashiki City, Okayama, Japan
The Sakakibara Heart Institute of Okayama
🇯🇵Okayama City, Okayama, Japan
Nakagami Hospital
🇯🇵Okinawa City, Okinawa, Japan
Ohama Daiichi Hospital
🇯🇵Naha City, Okinawa, Japan
Urasoe General Hospital
🇯🇵Urasoe City, Okinawa, Japan
Kawachi General Hospital
🇯🇵Higashi Osaka City, Osaka, Japan
Okinawa Nanbu Tokushukai Hospital
🇯🇵Shimajiri-gun, Okinawa, Japan
Kansai Medical University Hirakata Hospital
🇯🇵Hirakata City, Osaka, Japan
Kansai Medical University Takii Hospital
🇯🇵Moriguchi City, Osaka, Japan
Komatsu General Hospital
🇯🇵Neyagawa City, Osaka, Japan
Nissay Hospital
🇯🇵Osaka City, Osaka, Japan
Higashi-sumiyoshi Morimoto Hospital
🇯🇵Osaka City, Osaka, Japan
Osaka City University, Graduate School of Medicine
🇯🇵Osaka City, Osaka, Japan
Osaka Ekisaikai Hospital
🇯🇵Osaka City, Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka City, Osaka, Japan
Osaka General Hospital of West Japan Railway Campany
🇯🇵Osaka City, Osaka, Japan
Osaka Gyoumeikan Hospital
🇯🇵Osaka City, Osaka, Japan
Sakurabashi Watanabe Hospital
🇯🇵Osaka City, Osaka, Japan
Mimihara General Hospital
🇯🇵Sakai City, Osaka, Japan
Osaka Police Hospital
🇯🇵Osaka City, Osaka, Japan
Bell Land General Hospital
🇯🇵Sakai City, Osaka, Japan
Osaka University Graduate School of Medicine
🇯🇵Suita City, Osaka, Japan
Hokusetsu General Hospital
🇯🇵Takatsuki City, Osaka, Japan
Department of Cardiovascular Medicine, Saga University
🇯🇵Saga City, Saga, Japan
Mashiko Hospital
🇯🇵Kawaguchi City, Saitama, Japan
Saitama Medical Center, Jichi Medical University
🇯🇵Saitama City, Saitama, Japan
Kusatsu Heart Center
🇯🇵Kusatsu City, Shiga, Japan
Omihachiman Community Medical Center
🇯🇵Omihachiman City, Shiga, Japan
Shiga Medical Center for Adults
🇯🇵Moriyama City, Shiga, Japan
Biwako Ohashi Hospital
🇯🇵Otsu City, Shiga, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Ayase Heart Hospital
🇯🇵Adachi-ku, Tokyo, Japan
Tokushima Red Cross Hospital
🇯🇵Komatsujima City, Tokushima, Japan
Sakakibara Heart Institute
🇯🇵Fuchu City, Tokyo, Japan
Tokyo Metroporitan Tama Medical Center
🇯🇵Fuchu City, Tokyo, Japan
Itabashi Chuo Medical Center
🇯🇵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
NTT Medical Center Tokyo
🇯🇵Shinagawa-ku, Tokyo, Japan
Tottri University
🇯🇵Yonago City, Tottri, Japan
Non-profit organization Associations for Establishiment of Evidence in Interventions
🇯🇵Minato-ku, Tokyo, Japan
Hiroshima Railway Hospital
🇯🇵Hiroshima City, Hiroshima, Japan
Sugimura Hospital
🇯🇵Kumamoto City, Kumamoto, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama City, Okayama, Japan
St. Luke's International Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Nihon University School of Medicine
🇯🇵Itabashi-ku, Tokyo, Japan
Asahi General Hospital
🇯🇵Asahi City, Chiba, Japan
Fukuoka City Hospital
🇯🇵Fukuoka City, Fukuoka, Japan
Yokohama City UNiversity Medical Center
🇯🇵Yokohama City, Kanagawa, Japan
Kumamoto Chuo Hospital
🇯🇵Kumamoto City, Kumamoto, Japan
Saiseikai Senri Hospital
🇯🇵Suita City, Osaka, Japan
JR Tokyo General Hospital
🇯🇵Shibuya-ku, Tokyo, Japan
Matsuzaka Central General Hospital
🇯🇵Matsuzaka City, Mie, Japan
National Cerebral and Cardiovascular Center
🇯🇵Suita City, Osaka, Japan
Midorigaoka Hospital
🇯🇵Takatsuki City, Osaka, Japan
Hamamatsu Medical Center
🇯🇵Hamamatsu City, Shizuoka, Japan
Juntendo University Shizuoka Hospital
🇯🇵Izunokuni City, Shizuoka, Japan
Engaru-Kosei General Hospital
🇯🇵Monbetsu-gun, Hokkaido, Japan
Kanagawa Cardiovascular and Reppiratory Center
🇯🇵Yokohama City, Kanagawa, Japan
Osaka City General Hospital
🇯🇵Osaka City, Osaka, Japan
Kansai Rosai Hospital, Cardiovascular Center
🇯🇵Amagasaki City, Hyogo, Japan
Sagamihara Kyodo Hospital
🇯🇵Sagamihara City, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama City, Kanagawa, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu City, Shizuoka, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Shuto General Hospital
🇯🇵Yanai City, Yamaguchi, Japan
The Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo, Japan