Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose
Brief Summary: The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.


Options:
A: 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
B: 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)
C: Inclusion Criteria:

* Clinically stable participants may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either ST-elevation myocardial infarction \[STEMI\] or Non-STEMI or unstable angina)
* Participants not taking a statin must have an LDL-C of 125 mg/dl or less. Participants taking a statin must have an LDL-C of 100 mg/dl or less.

Exclusion Criteria:

* Pregnant or lactating woman, or intending to become pregnant
* Participant with active liver disease or persistent unexplained serum transaminase elevation
* History of alcohol or drug abuse
* History of sensitivity to statin or ezetimibe
* A participant for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
D: Inclusion Criteria:

* Subject has provided informed consent.
* Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:

  * \< 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk equivalent
  * \< 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent
  * OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD
* Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

* New York Heart Association (NYHA) II-IV heart failure, or last known left ventricular ejection fraction \< 30%
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization, type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes
* Uncontrolled hypertension

Answer: A