PERFORMANCE OF BIORESORBABLE POLYMER-COATED EVEROLIMUS-ELUTING SYNERGY® STENT IN PATIENTS AT HIGH BLEEDING RISK UNDERGOING PERCUTANEOUS CORONARY REVASCULARIZATION FOLLOWED BY 1-MONTH DUAL ANTIPLATELET THERAPY - POEM

IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 1,023 人开始时间: 2018年9月14日最近更新: 2021年8月17日

适应症

试验速览

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•a)Written, signed informed consent;
•b)Age =18 years;
•c)Patients at high bleeding risk (HBR) with symptomatic coronary artery disease, including patients with chronic stable angina, silent ischemia, or acute coronary syndromes (including NSTE-ACS and STE-ACS);
•d)Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft that treated with one or multiple Synergy® stents;
•e) PCI with the implantation of at least one Synergy® Stent System within 12 hours prior to inclusion
•Moreover, in order to be included patients will need to meet at least 1 of the following HBR criteria:
•1.Age =75 years
•2.Oral anticoagulation planned to continue after PCI
•3.Hemoglobin <11 g/l,
•4.Transfusion within 4 week before inclusion
•5.Platelet count <100’000/ml
•6.Hospital admission for bleeding in previous 12 months
•7.Stroke in previous 12 months
•8.History of intracerebral hemorrhage
•9.Severe chronic liver disease
•10.Creatinine clearance <40 ml/min
•11.Cancer in previous 3 years
•12.Planned major surgery in next 12 months
•13.Glucocorticoids or NSAID planned for >30 days after PCI
•14.Expected non-adherence to >30 days of dual antiplatelet therapy
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 323
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 700

•a)Cardiogenic shock
•b)Major active bleeding at the time of PCI
•c)Expected non-adherence with 1 month DAPT
•d)Known intolerance to ASA, clopidogrel or ticagrelor or any of the excipients
•e)Currently participating in another trial
•f)Pregnancy or lactation
•Note: there will be no exclusion based on mode of clinical presentation (with the exception of cardiogenic shock), co-morbidities, left ventricular function, number of diseased vessels and lesions, or number and type of target lesions

发起方

IRCCS ISTITUTO CLINICO HUMANITAS