Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis
Brief Summary: The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.


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:

1. American Indian men and women 40 years of age or older
2. Type 2 DM (according to 1997 ADA criteria and/or previously diagnosed by former ADA or WHO criteria): fasting plasma glucose \>= 7.0 mmol/L (126 mg/dL) or 2-hour glucose \>= 11.0 mmol/L (\>200 mg/dL) after a 75-gram oral glucose tolerance test.
3. LDL cholesterol \>= 100 mg/dL. within the previous 12 months.
4. Systolic BP \>= 130 mm Hg. within the previous 12 months.

Exclusion Criteria:

1. New York Heart Association Stage III- IV congestive heart failure.
2. SBP \>180 mmHg (2% of population) or patients with known causes of hypertension.
3. History of angioedema.
4. Any medical condition that study physicians believe would interfere with study participation or evaluation of results.
5. Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
6. Serum hepatic transaminase levels 2X the upper limit of normal.
7. Participation in any clinical trial of any investigational medication within 3 months prior to this trial.
8. Renal insufficiency as indicated by serum creatinine \>2.0 for women and \>2.4 for men.
9. Diagnosis of primary hyperlipidemia in medical record.
10. Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible.
11. Presence of malignancy or history of any cancer except skin cancer within the past 5 years.
12. Pregnancy or lactation. Premenopausal women will be requested to use birth control methods throughout the study and provided educational materials about the risks of using the study medications during pregnancy.
13. Unable to obtain quantifiable carotid measure during screening examination.
14. Concomitant long term use of cyclosporins (Sandimmune), macrolide antibiotics (erythromycin -many generic and brand name forms, clarithromycin, Biaxin, and Zithromax), azole antifungals (itraconazole-Sporanox, ritonavir, Norvir, and nelfinavir (Viracept).
15. Orthostatic hypotension as defined by the following:

    1. The individual has a measured fall of \>20 mmHg in systolic BP upon standing associated with symptoms lasting more than one minute (or severe symptoms that would not allow further lowering of BP)
    2. The standing systolic blood pressure is less than 90 mm.
16. Triglyceride level \>350 mg/dl.
17. Severe aortic stenosis with valve area \<=1.0 square cm.
C: Inclusion Criteria:

* Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram.

Exclusion Criteria:

* Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.
D: Inclusion Criteria:

* Male or female ≥ 18 to ≤ 80 years of age
* National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
* Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \<190 mg/dL
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

* History of coronary heart disease
* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
* Uncontrolled hypothyroidism or hyperthyroidism

Answer: C