Acute myocardial infarction
Conditions
Interventions
Synergy (Everolimus-eluting stent with biodegradable polymer)
Xience Alpine (Everolimus-eluting stent with durable polymer)
Sponsors
Tokorozawa Heart Center Clinical trial unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age =>18 years 2.Primary PCI within 24 hours of symptom onset 3.ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguuoius anterior leads 4.Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents
Exclusion criteria
Exclusion criteria: 1.Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. 2.Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material 3.Inability to understand and provide informed consent 4.Currently participating in another trial before reaching first endpoint 5.Mechanical complications of acute myocardial infarction 6.Acute myocardial infarction secondary to stent thrombosis or restenosis 7.Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period 8.Noncardiac comorbid conditions are present with life expectancy <3years or that may result in protocol noncompliance 9.History of bleeding diathesis or known coagulopathy 10.Use of oral anticoagulation 11.Age >=90 years 12.LV-function at index procedure <=20% 13.Cancer under active treatment (chemotherapy) 14.Hemodynamic instability following primary PCI 15.Chronic kidey disease (Creatinine - Clearance < 30ml/min) 16.OCT technically not feasible (severe calcification, tortuosity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of neoatherosclerosis lesion which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of >= 1 mm at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| The athero-thrombotic material area (tissue protorusion + isolated intraluminal detect) within the stent strut after primary PCI | — |
Countries
Japan,Europe
Contacts
Public ContactHiroyuki Negishi
Tokorozawa Heart Center General Affairs Division
Outcome results
None listed