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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O-APT group | Experimental | 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 |
|
| S-APT group | Active Comparator | ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Procedure | PCI with stent implantation |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PLATO-defined any minor bleeding event | 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. | Up to 36 months after PCI |
| PLATO-defined any minimal bleeding event |
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.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Lianglong, MD, PhD | Contact | +86-13950303022 | lianglongchen@126.com | |
| Ye Mingfang, MD | Contact | +86-13365910160 | xieheyemingfang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Lianglong, MD, PhD | Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Union Hospital, Fujian Medical University | Recruiting | Fuzhou | Fujian | 350001 | China |
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| Ticagrelor plus aspirin | Drug | Ticagrelor plus aspirin |
|
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 |
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. |
| Up to 36 months after PCI |
| Other adverse events | To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee. | Up to 36 months after PCI |
| Increase of serum uric acid or creatinine | To compare two intensities of ticagrelor therapy on increase of serum uric acid or creatinine.Events were adjudicated by an endpoint committee. | Up to 36 months after PCI |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| D000077486 | Ticagrelor |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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