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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT00127218
Eligibility Criteria:
Inclusion Criteria:
* Aged 65 or older
* Documented clinical cardiovascular or cerebrovascular disease due to atherosclerosis
* Candidate for lipid lowering therapy; no contraindication to fluvastatin, niacin or aspirin therapy
* Low-density lipoprotein (LDL) cholesterol below 150 mg/dl if untreated or below 125 mg/dl on statin monotherapy
* Willing to discontinue present therapy if private physician agrees with enrollment
* Eligible to undergo trans-esophageal magnetic resonance imaging (MRI); no contraindications to Gadolinium-DTPA, the contrast agent used
* Willing to sign Informed Consent
Exclusion Criteria:
* Ineligibility for MRI procedure due to pacemaker, metal implants, or other ferromagnetic devices
* Claustrophobia
* Previously documented esophageal disease which would preclude trans-esophageal MRI
* LDL-C greater than 150 mg/dl off lipid lowering therapy or daily statin therapy requiring doses greater than 20 mg of atorvastatin, 20 mg of simvastatin, 80 mg of lovastatin, 80 mg of pravastatin, 80 mg of extended release fluvastatin, or 20 mg of rosuvastatin
* Contraindication or allergy to statins or aspirin
* Current use of or known intolerance or allergy to Niaspan (a long-acting niacin)
* Allergy or intolerance to Gadolinium-DTPA (MRI contrast agent)
* Liver or kidney failure defined clinically and by laboratory data
* Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00127218
Study Brief:
Protocol Section:
NCT00127218