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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,187
DAPT using aspirin 81 mg/day (minimal dose) and clopidogrel 75 mg/day should be conducted for 3 months (+ 30 days) after stenting.
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
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).
Time frame: 12 months
Stent thrombosis
Incidence of stent thrombosis as per the definition by academic research council
Time frame: 12 months
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).
Time frame: 1, 3, 6, 9 and 12 months
TVR (target vessel revascularization)
Incidence of target vessel revascularization at months 9 and 12 after stenting.
Time frame: 9 and 12 months
TLR (target lesion revascularization)
Incidence of target lesion revascularization at months 9 and 12 after stenting.
Time frame: 9 and 12 months
DAPT compliance
Duration of DAPT and patient compliance.
Time frame: 12 months
Hemorrhagic complications
Incidence of hemorrhagic complications. (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding)
Time frame: 12 months
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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
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