Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Effect of Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI

Conditions
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Acute Coronary Syndrome, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention
* Drug: Ticagrelor plus aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment Enrollment into the study will require meeting at least one of these clinical syndromes. Unstable angina Non-ST elevation myocardial infarction (NSTEMI) ST elevation MI (STEMI) Non predominant coronary artery disease, it is defined as: exclusion of left main artery disease or left main artery bifurcated disease or ostial left anterior descending disease by coronary angiography imaging, and other high-risk vascular diseases considered by surgeons Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure Exclusion Criteria: Complications during stenting for coronary artery disease Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula Any planned surgery within 6 months any reason why any antiplatelet therapy might need to be discontinued within 12 months Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 15ml/min/1.73m^2 Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants) Platelet count < 100,000 mm^3 Contraindication to aspirin Contraindication to ticagrelor Liver cirrhosis Women of child-bearing potential Life expectancy < 1 year Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: O-APT group<br>Ticagrelor 90 mg twice daily plus aspirin 100mg once daily in the first month, Ticagrelor 90mg bid between the second and the sixth months Ticagrelor 45mg bid between the seventh and the twelfth months | Procedure: Percutaneous coronary intervention<br>* PCI with stent implantation<br>* Other names: PCI;Drug: Ticagrelor plus aspirin<br>* Ticagrelor plus aspirin<br>|
| Active Comparator: S-APT group<br>ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months | Procedure: Percutaneous coronary intervention<br>* PCI with stent implantation<br>* Other names: PCI;Drug: Ticagrelor plus aspirin<br>* Ticagrelor plus aspirin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major 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. | 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. | Up to 12 months after PCI | 
| The net adverse clinical events | included major adverse cardiovascular and cerebrovascular events or major bleeding events. | Up to 12 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with myocardial infarction (MI) event. | Number of participants with MI event. Events were adjudicated by an endpoint committee. | 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. | 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. | 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. | Up to 36 months after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiplatelet therapy, Non-predominant coronary artery disease, Ticagrelor, aspirin