Acute Coronary Syndrome, Percutaneous Coronary Intervention
Conditions
Keywords
antiplatelet therapy, Non-predominant coronary artery disease, Ticagrelor, aspirin
Brief summary
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
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.
Interventions
PROCEDUREPercutaneous coronary intervention
PCI with stent implantation
Ticagrelor plus aspirin
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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. 1. Unstable angina 2. Non-ST elevation myocardial infarction (NSTEMI) 3. 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular and cerebrovascular adverse events | Up to 12 months after PCI | 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. |
| The net adverse clinical events | Up to 12 months after PCI | included major adverse cardiovascular and cerebrovascular events or major bleeding events. |
| Major bleeding events | Up to 12 months after PCI | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants with death from cardiovascular causes. | Up to 36 months after PCI | Number of participants with death from cardiovascular causes. Events were adjudicated by an endpoint committee. |
| Participants with myocardial infarction (MI) event. | Up to 36 months after PCI | Number of participants with MI event. Events were adjudicated by an endpoint committee. |
| Participants with death from any cause. | Up to 36 months after PCI | Number of participants with death from any cause. Events were adjudicated by an endpoint committee. |
| PLATO-defined any bleeding event. | Up to 36 months after PCI | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PLATO-defined any minimal bleeding event | Up to 36 months after PCI | To compare two intensities of ticagrelor therapy on minimal bleeding event as all other bleeding(eg, bruising, bleeding gums, oozing from injection site) not requiring intervention or treatment.Events were adjudicated by an endpoint committee. |
| Increase of serum uric acid or creatinine | Up to 36 months after PCI | To compare two intensities of ticagrelor therapy on increase of serum uric acid or creatinine.Events were adjudicated by an endpoint committee. |
| PLATO-defined any minor bleeding event | Up to 36 months after PCI | To compare two intensities of ticagrelor therapy on minor bleeding event as any bleeding requiring medical intervention but not meeting the criteria for major bleeding. Events were adjudicated by an endpoint committee. |
| Other adverse events | Up to 36 months after PCI | To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee. |
Countries
China
Contacts
Primary ContactChen Lianglong, MD, PhD
Backup ContactYe Mingfang, MD
Outcome results
None listed