Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients

Coronary Artery Disease Clinical Trial

— OPERA  

Official title:

Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients: A Prospective Multicenter Registry (OPERA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325935
• Other study ID #: OPERA 1.0 - AEEI
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2011
• Last updated: January 5, 2016
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Associations for Establishment of Evidence in Interventions
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1187
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
DAPT using aspirin 81 mg/day (minimal dose) and clopidogrel 75 mg/day should be conducted for 3 months (+ 30 days) after stenting.

Locations

Country	Name	City	State
Japan	Ayase Heart Hospital	Adachi-ku	Tokyo
Japan	Hyogo Prefectural Amagasaki Hospital	Amagasaki City	Hyogo
Japan	Kansai Rosai Hospital, Cardiovascular Center	Amagasaki City	Hyogo
Japan	Asahi General Hospital	Asahi City	Chiba
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	Ebina General Hospital	Ebina City	Kanagawa
Japan	Sakakibara Heart Institute	Fuchu City	Tokyo
Japan	Tokyo Metroporitan Tama Medical Center	Fuchu City	Tokyo
Japan	Fujisawa City Hospital	Fujisawa City	Kanagawa
Japan	Fukui Cardiovascular Center	Fukui City	Fukui
Japan	Fukuoka City Hospital	Fukuoka City	Fukuoka
Japan	Fukuoka City Medical Association Hospital	Fukuoka City	Fukuoka
Japan	Fukuoka Red Cross Hospital	Fukuoka City	Fukuoka
Japan	Fukuyama City Hospital	Fukuyama City	Hiroshima
Japan	Gifu Heart Center	Gifu City	Gifu
Japan	Hamamatsu Medical Center	Hamamatsu City	Shizuoka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu City	Shizuoka
Japan	Kawachi General Hospital	Higashi Osaka City	Osaka
Japan	Kansai Medical University Hirakata Hospital	Hirakata City	Osaka
Japan	Hiroshima Railway Hospital	Hiroshima City	Hiroshima
Japan	Tsuchiya General Hospital	Hiroshima City	Hiroshima
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	Juntendo University Shizuoka Hospital	Izunokuni City	Shizuoka
Japan	Kagoshima University Hospital	Kagoshima City	Kagoshima
Japan	Tenyoukai Central Hospital	Kagoshima City	Kagoshima
Japan	Kanazawa University Hospital	Kanazawa City	Ishikawa
Japan	Mashiko Hospital	Kawaguchi City	Saitama
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	Synthesis Shinkawahashi Hospital	Kawasaki City	Kanagawa
Japan	Kimitsu Chuo Hospital	Kisarazu City	Chiba
Japan	University of Occupational and Environmental Health	Kita-Kyushu City	Fukuoka
Japan	Kobe City Medical Center General Hospital	Kobe City	Hyogo
Japan	Shakaihoken Kobe Central Hospital	Kobe City	Hyogo
Japan	National Hospital Organization Fukuoka-Higashi Medical Center	Koga City	Fukuoka
Japan	Tokushima Red Cross Hospital	Komatsujima City	Tokushima
Japan	Kumamoto Chuo Hospital	Kumamoto City	Kumamoto
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	Sugimura Hospital	Kumamoto City	Kumamoto
Japan	Kawasaki Medical School	Kurashiki City	Okayama
Japan	Kusatsu Heart Center	Kusatsu City	Shiga
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	Matsuzaka Central General Hospital	Matsuzaka City	Mie
Japan	Toho University Medical Center Ohashi Hospital	Meguro-ku	Tokyo
Japan	Miki City Hospital	Miki City	Hyogo
Japan	The Cardiovascular Institute	Minato-ku	Tokyo
Japan	The Jikei University Hospital	Minato-ku	Tokyo
Japan	Non-profit organization Associations for Establishiment of Evidence in Interventions	Minato-ku, Tokyo
Japan	Engaru-Kosei General Hospital	Monbetsu-gun	Hokkaido
Japan	Kansai Medical University Takii Hospital	Moriguchi City	Osaka
Japan	Shiga Medical Center for Adults	Moriyama City	Shiga
Japan	Nagasaki University Graduate School of Biomedical Science	Nagasaki City	Nagasaki
Japan	Ohama Daiichi Hospital	Naha City	Okinawa
Japan	Komatsu General Hospital	Neyagawa City	Osaka
Japan	Hyogo College of Medicine	Nishinomiya City	Hyogo
Japan	Meiwa General Hospital	Nishinomiya City	Hyogo
Japan	Odawara Cardiovascular Hospital	Odawara City	Kanagawa
Japan	National Hospital Organization Okayama Medical Center	Okayama City	Okayama
Japan	The Sakakibara Heart Institute of Okayama	Okayama City	Okayama
Japan	Nakagami Hospital	Okinawa City	Okinawa
Japan	Omihachiman Community Medical Center	Omihachiman City	Shiga
Japan	Higashi-sumiyoshi Morimoto Hospital	Osaka City	Osaka
Japan	Nissay Hospital	Osaka City	Osaka
Japan	Osaka City General 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 Hospital of West Japan Railway Campany	Osaka City	Osaka
Japan	Osaka General Medical Center	Osaka City	Osaka
Japan	Osaka Gyoumeikan Hospital	Osaka City	Osaka
Japan	Osaka Police Hospital	Osaka City	Osaka
Japan	Sakurabashi Watanabe Hospital	Osaka City	Osaka
Japan	Biwako Ohashi Hospital	Otsu City	Shiga
Japan	Department of Cardiovascular Medicine, Saga University	Saga City	Saga
Japan	Kitazato University School of Medicine	Sagamihara City	Kanagawa
Japan	Sagamihara Kyodo Hospital	Sagamihara City	Kanagawa
Japan	Gakken The Holy City Medical Association Hospital	Sagara-gun	Kyoto
Japan	Saitama Medical Center, Jichi Medical University	Saitama City	Saitama
Japan	Bell Land General Hospital	Sakai City	Osaka
Japan	Mimihara General Hospital	Sakai City	Osaka
Japan	Kaisei General Hospital	Sakaide City	Kagawa
Japan	JR Tokyo General Hospital	Shibuya-ku	Tokyo
Japan	Okinawa Nanbu Tokushukai Hospital	Shimajiri-gun	Okinawa
Japan	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo
Japan	National Cerebral and Cardiovascular Center	Suita City	Osaka
Japan	Osaka University Graduate School of Medicine	Suita City	Osaka
Japan	Saiseikai Senri Hospital	Suita City	Osaka
Japan	Hyogo Prefectural Awaji Hospital	Sumoto City	Hyogo
Japan	Suzuka Central General Hospital	Suzuka City	Mie
Japan	Hokusetsu General Hospital	Takatsuki City	Osaka
Japan	Midorigaoka Hospital	Takatsuki City	Osaka
Japan	Mie Heart Center	Taki-gun	Mie
Japan	Mie University Hospital	Tsu City	Mie
Japan	Uji Tokushukai Hospital	Uji City	Kyoto
Japan	Urasoe General Hospital	Urasoe City	Okinawa
Japan	Shuto General Hospital	Yanai City	Yamaguchi
Japan	Kanagawa Cardiovascular and Reppiratory Center	Yokohama 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	Yokohama City University Hospital	Yokohama City	Kanagawa
Japan	Yokohama City UNiversity Medical Center	Yokohama City	Kanagawa
Japan	Tottri University	Yonago City	Tottri

Sponsors (2)

Lead Sponsor	Collaborator
Associations for Establishment of Evidence in Interventions	Medtronic

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Stent thrombosis	Incidence of stent thrombosis as per the definition by academic research council	12 months	Yes
Secondary	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).	1, 3, 6, 9 and 12 months	Yes
Secondary	TVR (target vessel revascularization)	Incidence of target vessel revascularization at months 9 and 12 after stenting.	9 and 12 months	Yes
Secondary	TLR (target lesion revascularization)	Incidence of target lesion revascularization at months 9 and 12 after stenting.	9 and 12 months	Yes
Secondary	DAPT compliance	Duration of DAPT and patient compliance.	12 months	Yes
Secondary	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	Yes