Please select the eligibility criteria that correspond to the clinical trial below.
Title: Lupus Atherosclerosis Prevention Study
Brief Summary: Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk factors, and prothrombotic factors all playing important roles. Multiple groups have shown that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population, statins have become the drug of choice in preventing atherosclerotic events, through two mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT) and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role. This study will also determine whether statins improve clinical lupus activity or lupus serologies (anti-dsDNA and complement).


Options:
A: Inclusion Criteria

* Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen
* Body mass index between 18.0 and 35.0 kg/m2, inclusive
* For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day -2 or day -1
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant)during the full duration of the study
* Willing, committed and able to return for all the clinic visits and complete all study-related procedures
* Able to read, and able to sign the informed consent form

Exclusion Criteria:

* History of MI, ACS, Angina, Stroke, peripheral vascular disease, or cardiac revascularization
* Pregnant or breast-feeding women
* Blood donation of any volume within 1 month prior to administration of study drug
* Congestive heart failure
* Consumption of greater than 1 quart of grapefruit juice per day
* Previous exposure to any therapeutic or investigational biological agent within 30 days of screening
* History of alcohol or drug abuse within one year to the screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
B: Inclusion Criteria:

* Statin-naive (i.e., has never taken statins before)

Exclusion Criteria:

* Previous use of statins
* Current treatment with cholesterol- or triglyceride-lowering drugs
* Impaired liver or kidney function
* Untreated hypothyroidism or hyperthyroidism
* Treatment with other medications known to increase risk of myopathy in atorvastatin-treated patients (e.g., cyclosporine, azithromycin, erythromycin, azole antifungals, fusidic acid)
* Existing infection requiring treatment with antibiotic therapy
* Consumption of greater that 1 quart of grapefruit juice per day
* Documented history of neuroleptic malignant syndrome
* Inherited muscle disorders or myopathy
* Known sickle cell trait
* Cancer within the 5 years prior to study entry
* Diabetes
* Currently being treated for high blood pressure
* Coronary artery disease
* Peripheral vascular disease
* Physical disability or previous injury that prevents safe exercise testing
* Pregnant or breastfeeding
C: Inclusion Criteria:

* clinically defined lacunar syndrome 3 months before inclusion
* small deep infarct on diffusion MRI (Diffusion Weighted Imaging)
* no atherothrombotic, cardio-embolic, or other rarer cause.

Exclusion Criteria:

* patients with past coronary event
* contra-indication for assessment of vasomotor reactivity
* patients being on statin therapy at the time of brain infarction
* contra-indication for statin therapy
* patient still under statin therapy
D: Inclusion Criteria:

* Patients with a clinical diagnosis of SLE, confirmed by a faculty rheumatologist at Johns Hopkins.
* Patients must be 18 years of age or older
* Give informed consent.

Exclusion Criteria:

* SLE patients with a known atherosclerotic event, such as angina, myocardial infarction, or stroke, with an abnormal lipid profile for which a statin would be standard of care, are excluded.
* Pregnant patients (or patients planning to become pregnant in the next two years) are excluded.
* Patients who have known chronic liver disease, have unexplained elevation of their liver enzymes greater than 2 times the upper limit of normal , or an elevated CPK greater than 1.5 times the upper limit of the normal value for the patient's racial group, are excluded.
* Patients with triglycerides greater than 500 mg/dl or LDL greater than 190 in the absence of 2 risk factors (and who are unwilling to participate in a formal nutritional/lifestyle modification program that we recommend for them) are excluded.

Answer: D