Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial")
Brief Summary: Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.


Options:
A: Inclusion Criteria:

* Symptoms consistent with calf claudication and described as life style limiting
* Objective evidence of peripheral artery disease (PAD): Ankle brachial index less than 0.9 OR other hemodynamic or imaging modalities confirming significant PAD
* Baseline imaging reveals superficial femoral artery (SFA) disease starting at least 5 cm from the origin of the SFA
* Agrees to be available for follow-up and is able to participate in all study testing procedures
* Weight and/or body characteristics that will allow testing with MRI
* No known contraindication to lipid lowering agents
* Serum creatinine level less than 2.5 mg/dL
* Scheduled to undergo or has already undergone an endovascular intervention of a de novo lesion in the SFA with an anticipated result that would satisfy hemodynamic stability OR is medically managed and does not require an intervention at this time
* Compressible arteries (if not, has toe brachial index \[TBI\] less than 0.7)
* Has/had an A, B, C lesion amendable to a catheter based therapy (prior bypass is acceptable)

Exclusion Criteria:

* Non-atherosclerotic disease that is responsible for claudication
* Unstable cardiac disease (e.g., unstable angina, heart attack within the 30 days before study entry, uncontrolled coronary heart failure, poorly controlled hypertension \[systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg\], ventricular arrhythmias)
* Pancreatitis
* Documented hypercoagulable state
* Clinically severe diabetic neuropathy
* Rest pain, gangrene, or tissue loss
* Active peptic ulcer disease or a recent gastrointestinal bleed that would prohibit the use of an anti-platelet (aspirin/Plavix)
* Untreated or unsuccessfully controlled psychiatric disease
* Chronic hepatic disease determined by aspartate transaminase (AST) and/or alanine transaminase (ALT) more than 3 times upper limit of normal (ULN) and/or total bilirubin more than 2 times ULN
* Creatine phosphokinase (CPK) more than 3 times ULN (may be repeated once before patient is excluded)
* Active gout symptoms or a uric acid level greater than 1.3 times ULN
* Untreated hypothyroidism
* Allergy to Plavix, nickel, titanium, niacin, Ezetimibe, statins, or their derivatives
* Participated in another interventional study within the 30 days before study entry
* Scheduled to undergo planned synchronous bilateral percutaneous transluminal angioplasty (PTA) procedures
* Requires an above the ankle amputation
* Scheduled to undergo elective surgery within 30 days after the PTA procedure
* Has an implanted pacemaker, defibrillator, neural stimulator, brain clip, insulin pump, cochlear implant, or any other predetermined radiographic finding that would exclude MRI testing
* Has claustrophobia that would prevent MRI testing
* Recent drug or alcohol abuse history (less than 6 months before study entry) or is currently using or abusing excessive alcohol or drugs (excessive alcohol will be defined as greater than 14 drinks per week)
* Past recipient of a cardiac, kidney, liver, lung, or other organ transplant (skin grafts are acceptable)
B: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Persons with (initial or recurrent) confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who after a time period of at least 3 to 12 months are allowed to stop, - or stopped using \< 1 month anticoagulant treatment as indicated by their treating physician
* Persons aged 18 years or above

Exclusion Criteria:

* Persons already using statins or lipid lowering drugs, or any other disallowed concomitant medications (erythromycin, HIV protease inhibitors, or cyclosporine)
* History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
* Life expectancy less than 6 months
* Pregnant woman or woman with childbearing potential who are not willing to use contraception
* Active liver or kidney disease or dysfunction or muscle disorders
* Unstable medical or psychological condition that interferes with study participation
C: Inclusion Criteria:

* Men 50 years or older, women 60 years or older
* Low to normal levels of low density lipoprotein (LDL) cholesterol (\< 130mg/dL)
* Elevated levels of C-Reactive Protein (CRP) \> 2.0 mg/L

Exclusion Criteria:

* History of cardiovascular or cerebrovascular events
* Active liver disease
* Diabetes mellitus
* Uncontrolled hypertension or hypothyroidism
* History of certain malignancies
* Chronic inflammatory conditions
* History of alcohol or drug abuse
D: Inclusion Criteria:

* Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin
* Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study
* Patient is willing to remain abstinent or use birth control for the duration of the study
* Patient has Diabetes Mellitus with cardiovascular disease

Exclusion Criteria:

* Patient has sensitivity to certain common statin drugs
* Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design
* Patient consumes more than 2 alcoholic drinks per day
* Patient is pregnant or breast-feeding
* Patient has been treated with other investigational drugs within 30 days of first visit
* Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin
* Patient has congestive heart failure
* Patient has uncontrolled high blood pressure
* Patient has kidney disease
* Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins
* Patient has diabetes mellitus that is not well controlled
* Patient is human immunodeficiency virus (HIV) positive
* Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4)
* Patient is currently taking therapies that would increase the risk of muscle weakness
* Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1
* Patient is currently taking psyllium or other fiber-based laxatives

Answer: A