The study is to evaluate the effect of optimized 12-month step-down antiplatelet therapy (APT) compared with standard 12-month dual antiplatelet therapy in clinical net adverse events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome (ACS) who are not the predominant coronary artery disease after percutaneous coronary intervention (PCI).
This is a prospective, multi- center, randomized, parallel-group trial designed to evaluate the effect of optimized 12-month step-down antiplatelet therapy compared with standard 12-month dual antiplatelet therapy in clinical net adverse clinical events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome who are not the main coronary artery disease.2020 subjects will be enrolled. After PCI,eligible patients will be randomly assigned in a 1:1 ratio to either the optimized antiplatelet therapy group(O-APT)or the standard antiplatelet therapy group(S-APT). The primary efficacy end points are clinical net adverse clinical events ,or the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, ischemia driven coronary revascularization and stroke at 12 months. The primary safety end point is the incidence of PLATO major bleeding or Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,020
PCI with stent implantation
Ticagrelor plus aspirin
Department of Cardiology, Union Hospital, Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGMajor cardiovascular and cerebrovascular adverse events
Participants with death from cardiovascular causes, non-fatal myocardial infarction, stent thrombosis,Ischemia driven coronary revascularization and ischemic stroke.Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Time frame: Up to 12 months after PCI
Major bleeding events
Plato massive hemorrhage events, including fatal hemorrhage, intracranial hemorrhage, pericardial hemorrhage with pericardial tamponade, hypovolemic shock or severe hypotension caused by hemorrhage, requiring pressor or surgery, hemoglobin level dropping 5.0 g or more per deciliter, or at least requiring blood transfusion. Events were adjudicated by an endpoint committee. BARC type 2, 3 or 5 bleeding. Events were adjudicated by an endpoint committee.
Time frame: Up to 12 months after PCI
The net adverse clinical events
included major adverse cardiovascular and cerebrovascular events or major bleeding events.
Time frame: Up to 12 months after PCI
Participants with myocardial infarction (MI) event.
Number of participants with MI event. Events were adjudicated by an endpoint committee.
Time frame: Up to 36 months after PCI
Participants with death from cardiovascular causes.
Number of participants with death from cardiovascular causes. Events were adjudicated by an endpoint committee.
Time frame: Up to 36 months after PCI
Participants with death from any cause.
Number of participants with death from any cause. Events were adjudicated by an endpoint committee.
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Time frame: Up to 36 months after PCI
PLATO-defined any bleeding event.
Number of participants with any other bleeding events (minor bleeding or minimal bleeding) as defined by the PLATO. Events were adjudicated by an endpoint committee.
Time frame: Up to 36 months after PCI