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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term DAPT group | Experimental | 1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and clopidogrel) |
|
| Long-term DAPT group | No Intervention | 1,200 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | DAPT using aspirin 81 mg/day (minimal dose) and clopidogrel 75 mg/day should be conducted for 3 months (+ 30 days) after stenting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis | Incidence of stent thrombosis as per the definition by academic research council | 12 months |
| MACE (major adverse cardiac events) | 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). |
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Inclusion Criteria:
Clinical inclusion criteria
Coronary angiographic inclusion criteria:
Exclusion Criteria:
Clinical exclusion criteria
Angiographic exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asahi General Hospital | Asahi | Chiba | Japan | |||
| Kimitsu Chuo Hospital |
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| 1, 3, 6, 9 and 12 months |
| TVR (target vessel revascularization) | Incidence of target vessel revascularization at months 9 and 12 after stenting. | 9 and 12 months |
| TLR (target lesion revascularization) | Incidence of target lesion revascularization at months 9 and 12 after stenting. | 9 and 12 months |
| DAPT compliance | Duration of DAPT and patient compliance. | 12 months |
| Hemorrhagic complications | Incidence of hemorrhagic complications. (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding) | 12 months |
| 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 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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