Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention
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 Randomized Controlled Study
Fu Wai Hospital, Beijing, China
1,220 participants
Feb 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria19
- 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
- Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative \<55 years old or in first-degree female relative \<65 years old)
- Repeated myocardial infarction
- Positive serum cardiac troponin I/T
- Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
- Type 2 diabetes mellitus under medication
- Chronic kidney disease (eGFR\<60 mL/min/1.73 m2 or CrCl\<60ml/min)
- 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 Criteria10
- 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
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Interventions
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Locations(1)
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NCT04240834