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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01233167
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years of older.
* The latest PCI with DES implantation before 12 months (stents must be one or more sirolimus-eluting stents).
* Angiographically confirmed major epicardial vessels (\>=2.5mm in diameter) without significant stenosis or restenosis (\>=50%).
* Geographically accessible and willing to come in for required study visits.
* Signed informed consent.
Exclusion Criteria:
* The patient has a known hypersensitivity or contraindication to aspirin and clopidogrel.
* Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment and within 12 months.
* EF\<35% within 12 months.
* Severe cardiac valves disease, or idiopathic cardiomyopathy such as dilated cardiomyopathy, hypotrophic cardiomyopathy. Other severe system diseases.
* Previous ACS within 12 months.
* Previous stroke or transient ischemia attack within 12 months.
* Previous myocardial infarction and clinical-driven target vessel revascularization within 12 months.
* Current enrollment in another clinical trial.
* Suspected pregnancy.
* Big bleeding events within 12 months.
* Planned surgical procedure.
* Previous other type DES implantation or BMS implantation history.
* Extra-cardiac stent implantation history.
* Current or planned dialysis.
* The patient has a known hypersensitivity or contraindication to statins.
* Current or planned high dose and long-term glucocorticoid treatment.
* that is expected to limit survival to less than 1 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01233167
Study Brief:
Protocol Section:
NCT01233167