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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Clopidogrel	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1187 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients: A Prospective Multicenter Registry (OPERA)
Study Start Date :	April 2011
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Short-term DAPT group; 1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and clopidogrel)	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.
No Intervention: 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)

Outcome Measures

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Primary Outcome Measures :

1. NACCE (Net adverse clinical and cerebral event) [ Time Frame: 12 months ]
   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).

Secondary Outcome Measures :

1. Stent thrombosis [ Time Frame: 12 months ]
   Incidence of stent thrombosis as per the definition by academic research council
2. MACE (major adverse cardiac events) [ Time Frame: 1, 3, 6, 9 and 12 months ]
   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).
3. TVR (target vessel revascularization) [ Time Frame: 9 and 12 months ]
   Incidence of target vessel revascularization at months 9 and 12 after stenting.
4. TLR (target lesion revascularization) [ Time Frame: 9 and 12 months ]
   Incidence of target lesion revascularization at months 9 and 12 after stenting.
5. DAPT compliance [ Time Frame: 12 months ]
   Duration of DAPT and patient compliance.
6. Hemorrhagic complications [ Time Frame: 12 months ]
   Incidence of hemorrhagic complications. (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding)

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Sponsors and Collaborators

Associations for Establishment of Evidence in Interventions

Medtronic

Investigators

Principal Investigator:	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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier:	NCT01325935 History of Changes
Other Study ID Numbers:	OPERA 1.0 - AEEI
First Posted:	March 30, 2011
Last Update Posted:	January 7, 2016
Last Verified:	January 2016

Keywords provided by Associations for Establishment of Evidence in Interventions:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Disease; Cardiovascular Disease	Arteriosclerosis; Arterial Occlusive Disease; Vascular Disease; Clopidogrel; Platelet Aggregation Inhibitors

Additional relevant MeSH terms:

Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Vascular Diseases; Aspirin; Ticlopidine; Clopidogrel; Platelet Aggregation Inhibitors; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents