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Coronary Artery DiseasePhase 4OPERANCT01325935

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

A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 112 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,187 participants
Where
112 sitesJapan
Study dates
Apr 2011to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

112 sites in 1 country.

112 sites in 1 country

Japan112 sites

  • Ayase Heart Hospital

    Adachi-ku, Tokyo

  • Hyogo Prefectural Amagasaki Hospital

    Amagasaki, Hyōgo

  • Kansai Rosai Hospital, Cardiovascular Center

    Amagasaki, Hyōgo

  • Asahi General Hospital

    Asahi, Chiba

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo

  • St. Luke's International Hospital

    Chuo-ku, Tokyo

  • Ebina General Hospital

    Ebina, Kanagawa

  • Sakakibara Heart Institute

    Fuchū, Tokyo

  • Tokyo Metroporitan Tama Medical Center

    Fuchū, Tokyo

  • Fujisawa City Hospital

    Fujisawa, Kanagawa

  • Fukui Cardiovascular Center

    Fukui-shi, Fukui

  • Fukuoka City Hospital

    Fukuoka, Fukuoka

  • Fukuoka City Medical Association Hospital

    Fukuoka, Fukuoka

  • Fukuoka Red Cross Hospital

    Fukuoka, Fukuoka

  • Fukuyama City Hospital

    Fukuyama, Hiroshima

  • Gifu Heart Center

    Gifu, Gifu

  • Hamamatsu Medical Center

    Hamamatsu, Shizuoka

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka

  • Kawachi General Hospital

    Higashiosaka, Osaka

  • Kansai Medical University Hirakata Hospital

    Hirakata, Osaka

  • Hiroshima Railway Hospital

    Hiroshima, Hiroshima

  • Tsuchiya General Hospital

    Hiroshima, Hiroshima

  • Juntendo University Shizuoka Hospital

    Izunokuni, Shizuoka

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken

  • Tenyoukai Central Hospital

    Kagoshima, Kagoshima-ken

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken

  • Mashiko Hospital

    Kawaguchi, Saitama

  • Kawasaki Municipal Tama Hospital

    Kawasaki, Kanagawa

  • St. Marianna University of Medicine, Toyoko Hospital

    Kawasaki, Kanagawa

  • St. Marianna University School of Medicine

    Kawasaki, Kanagawa

  • Synthesis Shinkawahashi Hospital

    Kawasaki, Kanagawa

  • Kimitsu Chuo Hospital

    Kisarazu, Chiba

  • University of Occupational and Environmental Health

    Kita-Kyushu City, Fukuoka

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo

  • Shakaihoken Kobe Central Hospital

    Kobe, Hyōgo

  • National Hospital Organization Fukuoka-Higashi Medical Center

    Koga, Fukuoka

  • Tokushima Red Cross Hospital

    Komatsushimachō, Tokushima

  • Kumamoto Chuo Hospital

    Kumamoto, Kumamoto

  • Kumamoto Red Cross Hospital

    Kumamoto, Kumamoto

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, Kumamoto

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto

  • Sugimura Hospital

    Kumamoto, Kumamoto

  • Kawasaki Medical School

    Kurashiki, Okayama-ken

  • Kusatsu Heart Center

    Kusatsu, Shiga

  • Ijinkai Takeda General Hospital

    Kyoto, Kyoto

  • Koseikai Takeda Hospital

    Kyoto, Kyoto

  • Kyoto Second Red Cross Hospital

    Kyoto, Kyoto

  • Matsuzaka Central General Hospital

    Matsuzaka City, Mie-ken

  • Toho University Medical Center Ohashi Hospital

    Meguro-ku, Tokyo

  • Miki City Hospital

    Miki, Hyōgo

  • The Cardiovascular Institute

    Minato-ku, Tokyo

  • The Jikei University Hospital

    Minato-ku, Tokyo

  • Non-profit organization Associations for Establishiment of Evidence in Interventions

    Minato-ku, Tokyo, 105-0013

  • Engaru-Kosei General Hospital

    Monbetsu-gun, Hokkaido

  • Kansai Medical University Takii Hospital

    Moriguchi, Osaka

  • Shiga Medical Center for Adults

    Moriyama, Shiga

  • Nagasaki University Graduate School of Biomedical Science

    Nagasaki, Nagasaki

  • Ohama Daiichi Hospital

    Naha, Okinawa

  • Komatsu General Hospital

    Neyagawa, Osaka

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo

  • Meiwa General Hospital

    Nishinomiya, Hyōgo

  • Odawara Cardiovascular Hospital

    Odawara, Kanagawa

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken

  • The Sakakibara Heart Institute of Okayama

    Okayama, Okayama-ken

  • Nakagami Hospital

    Okinawa, Okinawa

  • Omihachiman Community Medical Center

    Ōmihachiman, Shiga

  • Higashi-sumiyoshi Morimoto Hospital

    Osaka, Osaka

  • Nissay Hospital

    Osaka, Osaka

  • Osaka City General Hospital

    Osaka, Osaka

  • Osaka City University, Graduate School of Medicine

    Osaka, Osaka

  • Osaka Ekisaikai Hospital

    Osaka, Osaka

  • Osaka General Hospital of West Japan Railway Campany

    Osaka, Osaka

  • Osaka General Medical Center

    Osaka, Osaka

  • Osaka Gyoumeikan Hospital

    Osaka, Osaka

  • Osaka Police Hospital

    Osaka, Osaka

  • Sakurabashi Watanabe Hospital

    Osaka, Osaka

  • Biwako Ohashi Hospital

    Ōtsu, Shiga

  • Department of Cardiovascular Medicine, Saga University

    Saga, Saga-ken

  • Kitazato University School of Medicine

    Sagamihara, Kanagawa

  • Sagamihara Kyodo Hospital

    Sagamihara, Kanagawa

  • Gakken The Holy City Medical Association Hospital

    Sagara-gun, Kyoto

  • Saitama Medical Center, Jichi Medical University

    Saitama, Saitama

  • Bell Land General Hospital

    Sakai, Osaka

  • Mimihara General Hospital

    Sakai, Osaka

  • Kaisei General Hospital

    Sakaidechō, Kagawa-ken

  • JR Tokyo General Hospital

    Shibuya-ku, Tokyo

  • Okinawa Nanbu Tokushukai Hospital

    Shimajiri-gun, Okinawa

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo

  • National Cerebral and Cardiovascular Center

    Suita, Osaka

  • Osaka University Graduate School of Medicine

    Suita, Osaka

  • Saiseikai Senri Hospital

    Suita, Osaka

  • Hyogo Prefectural Awaji Hospital

    Sumoto, Hyōgo

  • Suzuka Central General Hospital

    Suzuka, Mie-ken

  • Itabashi Chuo Medical Center

    tabashi City, Tokyo

  • Nihon University School of Medicine

    tabashi City, Tokyo

  • Teikyo University Hospital

    tabashi City, Tokyo

  • Tokyo Metroporitan Geriatric Hospital and Institute of Gerontology

    tabashi City, Tokyo

  • Hokusetsu General Hospital

    Takatsuki, Osaka

  • Midorigaoka Hospital

    Takatsuki, Osaka

  • Mie Heart Center

    Taki-gun, Mie-ken

  • Mie University Hospital

    Tsu, Mie-ken

  • Uji Tokushukai Hospital

    Uji, Kyoto

  • Urasoe General Hospital

    Urasoe, Okinawa

  • Shuto General Hospital

    Yanai, Yamaguchi

  • Kanagawa Cardiovascular and Reppiratory Center

    Yokohama, Kanagawa

  • Saiseikai Yokohama Tobu Hospital

    Yokohama, Kanagawa

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa

  • St. Marianna University of Medicine, Yokohama City West Hospital

    Yokohama, Kanagawa

  • Yokohama City University Hospital

    Yokohama, Kanagawa

  • Yokohama City UNiversity Medical Center

    Yokohama, Kanagawa

  • Tottri University

    Yonago, Tottri

Other trials in Japan

About this study

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

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.

Being tested
Clopidogrel
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Disease, Cardiovascular Disease, Arteriosclerosis, Arterial Occlusive Disease, Vascular Disease, Clopidogrel, Platelet Aggregation Inhibitors
Medical subject headings
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClopidogrelDrug

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

Study groups in NCT01325935
Study groupRoleWhat they receive
Short-term DAPT groupExperimental1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and clopidogrel)
Receives: Drug: Clopidogrel
Long-term DAPT groupNo intervention1,200 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months

Secondary outcomes (6)

  1. Stent thrombosis

    Incidence of stent thrombosis as per the definition by academic research council

    Measured: 12 months

  2. 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).

    Measured: 1, 3, 6, 9 and 12 months

  3. TVR (target vessel revascularization)

    Incidence of target vessel revascularization at months 9 and 12 after stenting.

    Measured: 9 and 12 months

  4. TLR (target lesion revascularization)

    Incidence of target lesion revascularization at months 9 and 12 after stenting.

    Measured: 9 and 12 months

  5. DAPT compliance

    Duration of DAPT and patient compliance.

    Measured: 12 months

  6. Hemorrhagic complications

    Incidence of hemorrhagic complications. (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionSep 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01325935
Sponsor's protocol ID
OPERA 1.0 - AEEI
Acronym
OPERA
Status last verified
Jan 2016
First submitted
29 Mar 2011
Last updated
7 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 112 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NACCE (Net adverse clinical and cerebral event) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01325935.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.

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