Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients (OPERA)
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|ClinicalTrials.gov Identifier: NCT01325935|
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : January 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1187 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Short-term DAPT group
1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and 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)
- 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).
- Stent thrombosis [ Time Frame: 12 months ]Incidence of stent thrombosis as per the definition by academic research council
- 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).
- TVR (target vessel revascularization) [ Time Frame: 9 and 12 months ]Incidence of target vessel revascularization at months 9 and 12 after stenting.
- TLR (target lesion revascularization) [ Time Frame: 9 and 12 months ]Incidence of target lesion revascularization at months 9 and 12 after stenting.
- DAPT compliance [ Time Frame: 12 months ]Duration of DAPT and patient compliance.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325935
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|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|