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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fu Wai Hospital, Beijing, China
• Treatments: Aspirin; Ticagrelor

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 inclusion and none of the exclusion criteria.

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