Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04240834
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04240834
Study Brief:
Protocol Section:
NCT04240834