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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01325818
Eligibility Criteria:
Inclusion Criteria:
1. Patients who have been diagnosed as stable angina pectoris, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) and optical coherence tomography (OCT) guidance.
2. Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.
3. Patients with dyslipidemia as defined by any of the following criteria:
* TC ≧ 220 mg/dL
* LDL-C ≧ 140 mg/dL
* Cholesterol-lowering treatment is allowed according to the investigator's judgment when LDL-C ≧ 100 mg/dL or TC ≧ 180mg/dL.
* Patients who are under cholesterol-lowering treatment and LDL-C ≦ 120 mg/dL
4. Patients 20 years or older at the time of their consent.
5. Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.
Exclusion Criteria:
1. Patients with bypass graft or in-stent restenosis at the site of PCI.
2. Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
3. Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
4. Patients receiving lipid-lowering drugs (fibrates, probucol, nicotinic acid, cholestyramine or cholesterol absorption inhibitors).
5. Patients with familial hypercholesterolemia.
6. Patients with cardiogenic shock.
7. Patients receiving cyclosporine.
8. Patients with any allergy to pravastatin and rosuvastatin.
9. Patients with hepatobiliary disorders.
10. Pregnant women, women suspected of being pregnant, or lactating women.
11. Patients with renal disorders (Cr≧2.0mg/dL) or undergoing dialysis.
12. Patients who are ineligible in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01325818
Study Brief:
Protocol Section:
NCT01325818