Clinical trial NCT01325935: Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients
Official title: Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients: A Prospective Multicenter Registry (OPERA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Disease
Cardiovascular Disease
Arteriosclerosis
Arterial Occlusive Disease
Vascular Disease
Clopidogrel
Platelet Aggregation Inhibitors
Lead sponsor: Associations for Establishment of Evidence in Interventions
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-03-30
Enrollment: 1187
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1. 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.
2. 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.

Primary outcomes:
measure: NACCE (Net adverse clinical and cerebral event)
timeFrame: 12 months
Secondary outcomes:
measure: Stent thrombosis
timeFrame: 12 months
measure: MACE (major adverse cardiac events)
timeFrame: 1, 3, 6, 9 and 12 months
measure: TVR (target vessel revascularization)
timeFrame: 9 and 12 months
measure: TLR (target lesion revascularization)
timeFrame: 9 and 12 months
measure: DAPT compliance
timeFrame: 12 months
measure: Hemorrhagic complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Asahi City
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Kisarazu City
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba
city: Fukui City
country: Japan
facility: Fukui Cardiovascular Center
state: Fukui
city: Fukuoka City
country: Japan
facility: Fukuoka City Hospital
state: Fukuoka
city: Fukuoka City
country: Japan
facility: Fukuoka City Medical Association Hospital
state: Fukuoka
city: Fukuoka City
country: Japan
facility: Fukuoka Red Cross Hospital
state: Fukuoka
city: Kita-Kyushu City
country: Japan
facility: University of Occupational and Environmental Health
state: Fukuoka
city: Koga City
country: Japan
facility: National Hospital Organization Fukuoka-Higashi Medical Center
state: Fukuoka
city: Gifu City
country: Japan
facility: Gifu Heart Center
state: Gifu
city: Fukuyama City
country: Japan
facility: Fukuyama City Hospital
state: Hiroshima
city: Hiroshima City
country: Japan
facility: Hiroshima Railway Hospital
state: Hiroshima
city: Hiroshima City
country: Japan
facility: Tsuchiya General Hospital
state: Hiroshima
city: Monbetsu-gun
country: Japan
facility: Engaru-Kosei General Hospital
state: Hokkaido
city: Amagasaki City
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital
state: Hyogo
city: Amagasaki City
country: Japan
facility: Kansai Rosai Hospital, Cardiovascular Center
state: Hyogo
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kobe City
country: Japan
facility: Shakaihoken Kobe Central Hospital
state: Hyogo
city: Miki City
country: Japan
facility: Miki City Hospital
state: Hyogo
city: Nishinomiya City
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Nishinomiya City
country: Japan
facility: Meiwa General Hospital
state: Hyogo
city: Sumoto City
country: Japan
facility: Hyogo Prefectural Awaji Hospital
state: Hyogo
city: Kanazawa City
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Sakaide City
country: Japan
facility: Kaisei General Hospital
state: Kagawa
city: Kagoshima City
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Kagoshima City
country: Japan
facility: Tenyoukai Central Hospital
state: Kagoshima
city: Ebina City
country: Japan
facility: Ebina General Hospital
state: Kanagawa
city: Fujisawa City
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Kawasaki City
country: Japan
facility: Kawasaki Municipal Tama Hospital
state: Kanagawa
city: Kawasaki City
country: Japan
facility: St. Marianna University of Medicine, Toyoko Hospital
state: Kanagawa
city: Kawasaki City
country: Japan
facility: St. Marianna University School of Medicine
state: Kanagawa
city: Kawasaki City
country: Japan
facility: Synthesis Shinkawahashi Hospital
state: Kanagawa
city: Odawara City
country: Japan
facility: Odawara Cardiovascular Hospital
state: Kanagawa
city: Sagamihara City
country: Japan
facility: Kitazato University School of Medicine
state: Kanagawa
city: Sagamihara City
country: Japan
facility: Sagamihara Kyodo Hospital
state: Kanagawa
city: Yokohama City
country: Japan
facility: Kanagawa Cardiovascular and Reppiratory Center
state: Kanagawa
city: Yokohama City
country: Japan
facility: Saiseikai Yokohama Tobu Hospital
state: Kanagawa
city: Yokohama City
country: Japan
facility: Showa University Fujigaoka Hospital
state: Kanagawa
city: Yokohama City
country: Japan
facility: St. Marianna University of Medicine, Yokohama City West Hospital
state: Kanagawa
city: Yokohama City
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Yokohama City
country: Japan
facility: Yokohama City UNiversity Medical Center
state: Kanagawa
city: Kumamoto City
country: Japan
facility: Kumamoto Chuo Hospital
state: Kumamoto
city: Kumamoto City
country: Japan
facility: Kumamoto Red Cross Hospital
state: Kumamoto
city: Kumamoto City
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
state: Kumamoto
city: Kumamoto City
country: Japan
facility: Saiseikai Kumamoto Hospital
state: Kumamoto
city: Kumamoto City
country: Japan
facility: Sugimura Hospital
state: Kumamoto
city: Kyoto City
country: Japan
facility: Ijinkai Takeda General Hospital
state: Kyoto
city: Kyoto City
country: Japan
facility: Koseikai Takeda Hospital
state: Kyoto
city: Kyoto City
country: Japan
facility: Kyoto Second Red Cross Hospital
state: Kyoto
city: Sagara-gun
country: Japan
facility: Gakken The Holy City Medical Association Hospital
state: Kyoto
city: Uji City
country: Japan
facility: Uji Tokushukai Hospital
state: Kyoto
city: Matsuzaka City
country: Japan
facility: Matsuzaka Central General Hospital
state: Mie
city: Suzuka City
country: Japan
facility: Suzuka Central General Hospital
state: Mie
city: Taki-gun
country: Japan
facility: Mie Heart Center
state: Mie
city: Tsu City
country: Japan
facility: Mie University Hospital
state: Mie
city: Nagasaki City
country: Japan
facility: Nagasaki University Graduate School of Biomedical Science
state: Nagasaki
city: Kurashiki City
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Okayama City
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Okayama City
country: Japan
facility: The Sakakibara Heart Institute of Okayama
state: Okayama
city: Naha City
country: Japan
facility: Ohama Daiichi Hospital
state: Okinawa
city: Okinawa City
country: Japan
facility: Nakagami Hospital
state: Okinawa
city: Shimajiri-gun
country: Japan
facility: Okinawa Nanbu Tokushukai Hospital
state: Okinawa
city: Urasoe City
country: Japan
facility: Urasoe General Hospital
state: Okinawa
city: Higashi Osaka City
country: Japan
facility: Kawachi General Hospital
state: Osaka
city: Hirakata City
country: Japan
facility: Kansai Medical University Hirakata Hospital
state: Osaka
city: Moriguchi City
country: Japan
facility: Kansai Medical University Takii Hospital
state: Osaka
city: Neyagawa City
country: Japan
facility: Komatsu General Hospital
state: Osaka
city: Osaka City
country: Japan
facility: Higashi-sumiyoshi Morimoto Hospital
state: Osaka
city: Osaka City
country: Japan
facility: Nissay Hospital
state: Osaka
city: Osaka City
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Osaka City
country: Japan
facility: Osaka City University, Graduate School of Medicine
state: Osaka
city: Osaka City
country: Japan
facility: Osaka Ekisaikai Hospital
state: Osaka
city: Osaka City
country: Japan
facility: Osaka General Hospital of West Japan Railway Campany
state: Osaka
city: Osaka City
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Osaka City
country: Japan
facility: Osaka Gyoumeikan Hospital
state: Osaka
city: Osaka City
country: Japan
facility: Osaka Police Hospital
state: Osaka
city: Osaka City
country: Japan
facility: Sakurabashi Watanabe Hospital
state: Osaka
city: Sakai City
country: Japan
facility: Bell Land General Hospital
state: Osaka
city: Sakai City
country: Japan
facility: Mimihara General Hospital
state: Osaka
city: Suita City
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Suita City
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Suita City
country: Japan
facility: Saiseikai Senri Hospital
state: Osaka
city: Takatsuki City
country: Japan
facility: Hokusetsu General Hospital
state: Osaka
city: Takatsuki City
country: Japan
facility: Midorigaoka Hospital
state: Osaka
city: Saga City
country: Japan
facility: Department of Cardiovascular Medicine, Saga University
state: Saga
city: Kawaguchi City
country: Japan
facility: Mashiko Hospital
state: Saitama
city: Saitama City
country: Japan
facility: Saitama Medical Center, Jichi Medical University
state: Saitama
city: Kusatsu City
country: Japan
facility: Kusatsu Heart Center
state: Shiga
city: Moriyama City
country: Japan
facility: Shiga Medical Center for Adults
state: Shiga
city: Omihachiman City
country: Japan
facility: Omihachiman Community Medical Center
state: Shiga
city: Otsu City
country: Japan
facility: Biwako Ohashi Hospital
state: Shiga
city: Hamamatsu City
country: Japan
facility: Hamamatsu Medical Center
state: Shizuoka
city: Hamamatsu City
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Izunokuni City
country: Japan
facility: Juntendo University Shizuoka Hospital
state: Shizuoka
city: Komatsujima City
country: Japan
facility: Tokushima Red Cross Hospital
state: Tokushima
city: Adachi-ku
country: Japan
facility: Ayase Heart Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Fuchu City
country: Japan
facility: Sakakibara Heart Institute
state: Tokyo
city: Fuchu City
country: Japan
facility: Tokyo Metroporitan Tama Medical Center
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Itabashi Chuo Medical Center
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University School of Medicine
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Tokyo Metroporitan Geriatric Hospital and Institute of Gerontology
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Medical Center Ohashi Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Cardiovascular Institute
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Shibuya-ku
country: Japan
facility: JR Tokyo General Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Yonago City
country: Japan
facility: Tottri University
state: Tottri
city: Yanai City
country: Japan
facility: Shuto General Hospital
state: Yamaguchi
city: Minato-ku, Tokyo
country: Japan
facility: Non-profit organization Associations for Establishiment of Evidence in Interventions
Study officials:
affiliation: Teikyo University
name: Takaaki Isshiki, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Osaka University
name: Shinsuke Nanto, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Toho University Ohashi Medical Center
name: Masato Nakamura, M.D.
role: PRINCIPAL_INVESTIGATOR
References: