Coronary artery disease with high-bleeding risk (HBR) MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 56 COMPRESSE (CONF. CALENDARIZZATA)
Product Name: Ticagrelor
Pharmaceutical Form: Film-coated tablet
INN
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk;Secondary Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk;Primary end point(s): Composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 1-year follow-up;Timepoint(s) of evaluation of this end point: 1-year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - All-cause death at 30 days and 1 year - Cardiac death at 30 days and 1 year - Myocardial infarction (according to the III Universal Definition) Definite/probable stent thrombosis (according to ARC criteria) at 30 days and 1 year - Definite stent thrombosis (according to ARC criteria) at 30 days and 1 year - Target-vessel revascularization (any and clinically-driven) at 30 days and 1 year - Target-lesion revascularization (any and clinically-driven) at 30 days and 1 year - Major bleeding (BARC 3 to 5) at 30 days and 1 year - Cerebrovascular events at 30 days and 1 year - Target-lesion failure (composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target lesion revascularization) at 30 days and 1 year - Patient oriented composite endpoint (composite of any death, any MI, any revascularization) at 30 days and 1 year;Timepoint(s) of evaluation of this end point: 30 days and 1 year | — |
Countries
Italy
Contacts
Public ContactCRO
CD Pharma Group S.r.l.
Outcome results
None listed