Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.

Detailed Description
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This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.

Official Title
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Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation,Single-center, Phase 3 Study

Conditions
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Acute Coronary Syndrome, Interventional Cardiology

Intervention / Treatment
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* Drug: Aspirin
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent Able and willing to provide informed consent and participate in 12 months follow-up period Able to receive DAPT treatment Enrollment into the study will require meeting at least one angiographic inclusion and none of the exclusion criteria. Angiographic Inclusion Criteria: LM lesion requiring stents Proximal LAD lesion(s) requiring stents Bypass grafts lesion(s) requiring stents Overall stent length ≥60 mm History of in-stent thrombosis Bifurcation lesions requiring at least 2 stents Over two vessels lesions requiring stents Calcified target lesion(s) requiring atherectomy The intraoperative occurrence of no-reflow or slow-flow Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3) Exclusion Criteria: Need for chronic oral anticoagulation With cardiomyopathy（HCM/DCM/RCM） With severe ventricular arrhythmia requiring ICD implantation With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease) With severe infectious disease（active hepatitis B, active hepatitis C, AIDS） With hematological disorders（thrombocytopenia, severe anemia, leukaemia） With severe liver disease or kidney failure With malignant tumor With cognitive impairment Unable or unwilling to provide informed consent or undergo follow-up

Ages Eligible for Study
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Minimum Age: 18 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: LD group<br>Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months | Drug: Aspirin<br>* Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)<br>* Other names: Acetylsalicylic Acid;Drug: Ticagrelor<br>* Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)<br>* Other names: Brilinta/Brilique;|
| Active Comparator: Control group<br>Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months | Drug: Aspirin<br>* Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)<br>* Other names: Acetylsalicylic Acid;Drug: Ticagrelor<br>* Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)<br>* Other names: Brilinta/Brilique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebral events (MACCEs) | Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization | 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding episode (Key secondary endpoint) | Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2) | 12 months after randomization | 
| Platelet function | Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2) | 12 months after randomization | 
| Medication adherence |  | 12 months after randomization | 
| Bleeding-related withdrawal |  | 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, PCI, DAPI, Aspirin, Ticagrelor