Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Disease, Cardiovascular Disease, Arteriosclerosis, Arterial Occlusive Disease, Vascular Disease, Clopidogrel, Platelet Aggregation Inhibitors
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.
Interventions
DRUGClopidogrel
DAPT using aspirin 81 mg/day (minimal dose) and clopidogrel 75 mg/day should be conducted for 3 months (+ 30 days) after stenting.
Sponsors
Medtronic
Associations for Establishment of Evidence in Interventions
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NACCE (Net adverse clinical and cerebral event) | 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
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis | 12 months | Incidence of stent thrombosis as per the definition by academic research council |
| MACE (major adverse cardiac events) | 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). |
| DAPT compliance | 12 months | Duration of DAPT and patient compliance. |
| TLR (target lesion revascularization) | 9 and 12 months | Incidence of target lesion revascularization at months 9 and 12 after stenting. |
| Hemorrhagic complications | 12 months | Incidence of hemorrhagic complications. (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding) |
| TVR (target vessel revascularization) | 9 and 12 months | Incidence of target vessel revascularization at months 9 and 12 after stenting. |
Countries
Japan
Outcome results
None listed