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

Phase 1

• Conditions: Coronary artery disease with high-bleeding risk (HBR); MedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004510-99-IT
• Lead Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-14
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1023

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 <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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): -All-cause death at 30 days and 1 year<br>-Cardiac death at 30 days and 1 year<br>-Myocardial infarction (according to the III Universal Definition) Definite/probable stent thrombosis (according to ARC criteria) at 30 days and 1 year<br>-Definite stent thrombosis (according to ARC criteria) at 30 days and 1 year<br>-Target-vessel revascularization (any and clinically-driven) at 30 days and 1 year<br>-Target-lesion revascularization (any and clinically-driven) at 30 days and 1 year<br>-Major bleeding (BARC 3 to 5) at 30 days and 1 year<br>-Cerebrovascular events at 30 days and 1 year<br>-Target-lesion failure (composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target lesion revascularization) at 30 days and 1 year<br>-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