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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

NCT04240834 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2021-02-01
Last updated
2024-06-18

Condition(s) studied

Acute Coronary SyndromeInterventional Cardiology

Investigational drug(s) / intervention(s)

Aspirin →Ticagrelor →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Fuwai Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04240834 on ClinicalTrials.gov ↗ ← All trials in China