A Phase 4 interventional study of Aspirin and P2Y12 inhibitor in Coronary Artery Disease and Acute Coronary Syndrome, sponsored by Humanitas Hospital, Italy. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Humanitas Hospital, Italy · Phase 4, Interventional, and Treatment
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.
Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions.
Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm, multicentre trial, powered for non-inferiority with respect to objective performance criteria (OPC).
Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.
Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 1-year follow-up.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 1,023 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Humanitas Hospital, Italy is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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All patients will need to have symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, or acute coronary syndromes (including NSTE-ACS and STE-ACS) and 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.
Moreover, in order to be included patients will need to meet at least 1 of the following HBR criteria:
Exclusion Criteria:
1023 real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions will be included in the study.
Drug: Aspirin · Drug: P2Y12 inhibitor
After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.
After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.
Major Adverse Cardiac Events (MACE)
Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis
Time frame: 1 year
All-cause death
All-cause death
Time frame: 30 days and 1 year
Cardiac death
Cardiac death
Time frame: 30 days and 1 year
Myocardial infarction
Myocardial infarction (defined according to III universal definition)
Time frame: 30 days and 1 year
Stent thrombosis
Stent thrombosis (defined according to ARC criteria)
Time frame: 30 days and 1 year
Target-vessel revascularization
Target-vessel revascularization (any and clinically driven)
Time frame: 30 days and 1 year
Target-lesion revascularization
Target-lesion revascularization (any and clinically driven)
Time frame: 30 days and 1 year
Major bleeding
Major bleeding (BARC 3 to 5)
Time frame: 30 days and 1 year
Cerebrovascular event
Cerebrovascular event
Time frame: 30 days and 1 year
Target-lesion failure
composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization
Time frame: 30 days and 1 year
Patient oriented composite endpoint
Composite of any death, any MI, any revascularization
Time frame: 30 days and 1 year
Plan to share: No
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Humanitas Hospital, Italy