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

Launched by FU WAI HOSPITAL, BEIJING, CHINA · Jan 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of Ticagrelor combined with a low dose of Aspirin to see how safe and effective it is compared to the standard treatment of Ticagrelor with regular Aspirin. The focus is on patients who have had a recent episode of Acute Coronary Syndrome (ACS) and are considered at high risk for future heart problems after a procedure called Percutaneous Coronary Intervention (PCI), where a stent is placed in the heart to keep the arteries open.

To participate in this trial, patients need to be between the ages of 65 and 74 and must have had successful PCI with at least one drug-eluting stent. They should also have certain risk factors, such as a family history of heart disease, diabetes, or kidney issues. Participants will be followed for 12 months, during which they will receive the study treatment and undergo regular check-ups. It’s important to note that certain health conditions, like severe respiratory diseases or cancer, may exclude someone from joining the study. This trial aims to find the best treatment option to help prevent future heart issues in these high-risk patients.

Gender

ALL

Eligibility criteria

• 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