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

NCT ID: NCT01325935

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short-term DAPT group

1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and clopidogrel)

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

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

Long-term DAPT group

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clopidogrel

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

Intervention Type: DRUG

Eligibility Criteria

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.

• 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

• 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).
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Associations for Establishment of Evidence in Interventions

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takaaki Isshiki, M.D.

Role: PRINCIPAL_INVESTIGATOR

Teikyo University

Shinsuke Nanto, M.D.

Role: PRINCIPAL_INVESTIGATOR

Osaka University

Masato Nakamura, M.D.

Role: PRINCIPAL_INVESTIGATOR

Toho University Ohashi Medical Center

Locations

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, , Japan

Countries

Japan

Other Identifiers

OPERA 1.0 - AEEI

Identifier Type: -

Identifier Source: org_study_id