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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01526460
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-75 years
* Patients with chronic stable angina
* Patients with coronary artery disease or with de novo stent restenosis of native vessels.
* Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent.
Exclusion Criteria:
* Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI).
* Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel.
* Altered basal level of transaminase or CPK.
* Patient with history of hepatitis-acute/chronic.
* Patients already receiving high-dose statins.
* Contraindications to antiplatelet therapy.
* Patients with acute inflammatory disease and/or underlying chronic (hepatitis, pneumonia, urinary tract, rectum ulcerative colitis etc.).
* Patients with anemia (haemoglobin \<8.5 mg/dl), leukocytosis (WBC\> 12.000 mm3), leukopenia (WBC \<3000 mm3), platelet count \<100.000; hypersplenism.
* Patients with malignant disease.
* Patients enrolled in other studies not yet completed.
* Patients with known allergy / intolerance to statins.
* Pregnant women and women who are breastfeeding.
* Patients with myopathy (muscle pain and unexplained repeated)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01526460
Study Brief:
Protocol Section:
NCT01526460