Recruiting
Phase 4
Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention
Condition(s) studied
Acute Coronary SyndromeInterventional Cardiology
Investigational drug(s) / intervention(s)
Aspirin: Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Ticagrelor: Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Study 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 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 or clinical inclusion and none of the exclusion criteria.
Clinical inclusion criteria:
1. 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)
2. Repeated myocardial infarction
3. Positive serum cardiac troponin I/T
4. Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
5. Type 2 diabetes mellitus under medication
6. Chronic kidney disease (eGFR\<60 mL/min/1.73 m2 or CrCl\<60ml/min)
Angiographic Inclusion Criteria:
1. LM lesion requiring stents
2. Proximal LAD lesion(s) requiring stents
3. Bypass grafts lesion(s) requiring stents
4. Overall stent length ≥60 mm
5. History of in-stent thrombosis
6. Bifurcation lesions requiring at least 2 stents
7. Over two vessels lesions requiring stents
8. Calcified target lesion(s) requiring atherectomy
9. The intraoperative occurrence of no-reflow or slow-flow
10. 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
Primary outcome measure(s)
- Major adverse cardiac and cerebral events (MACCEs) — 12 months after randomization
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
Trial sites (1)
| Facility | City | Region | Status |
| Fuwai Hospital |
Beijing |
Beijing Municipality |
Recruiting |
More Fu Wai Hospital, Beijing, China trials in China
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