Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective Randomized Open Label Blinded Endpoint Multicenter Study in Patients With Coronary Artery Disease to Assess the LDL Lowering Effect of Switching to Ezetimibe (+) Simvastatin for Cholesterol Lowering, Compared the Dose of the Statin Used.
Brief Summary: In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (\> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.


Options:
A: Inclusion Criteria:

* History of chronic kidney disease (CKD): either patients who are pre-dialysis (with a plasma or serum creatinine greater than or equal to 150 micromol/l \[greater than or equal to 1.7 mg/dl\] in men, or greater than or equal to 130 micromol/l \[greater than or equal to 1.5 mg/dl\] in women); or patients on dialysis (hemodialysis or peritoneal dialysis)
* Men or women aged greater than or equal to 40 years

Exclusion Criteria:

* Definite history of myocardial infarction or coronary revascularization procedure
* Functioning renal transplant, or living donor-related transplant planned
* Less than 2 months since presentation as an acute uraemic emergency (but could be entered later, if appropriate)
* Definite history of chronic liver disease, or abnormal liver function (i.e. alanine aminotransferase \[ALT\] greater than 1.5 x upper limit of normal \[ULN\] or, if ALT not available, aspartate aminotransferase \[AST\] greater than 1.5 x ULN). (Note: Patients with a history of hepatitis were eligible provided these limits were not exceeded.)
* Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (CK) greater than 3 x ULN
* Definite previous adverse reaction to a statin or to ezetimibe
* Concurrent treatment with a contraindicated drug. (Note: Patients who were temporarily taking such drugs could have been re-screened for participation in the study when they discontinued them, if appropriate.) These contraindicated drugs included: HMG-CoA reductase inhibitor ("statin"); fibric acid derivative ("fibrate"); nicotinic acid; macrolide antibiotic (erythromycin, clarithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease-inhibitors (e.g. antiretroviral drugs for HIV infection); nefazodone; ciclosporin
* Child-bearing potential (i.e. premenopausal woman who was not using a reliable method of contraception)
* Known to be poorly compliant with clinic visits or prescribed medication
* Medical history that might have limited the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)
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:

* 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
D: Inclusion Criteria:

* Patient is male or female 18 years of age.
* Patient is on a stable daily statin starting dose for the past 4 weeks of either: atorvastatin 10 mg or; simvastatin 20 mg
* lipid values while on statin monotherapy treatment: LDL-C level of \> 2.5 mmol/L to \* 5.0 mmol/L, triglycerides \< 4.0 mmol/L and total cholesterol \< 7.0 mmol/L.
* Patient with established coronary artery disease such as stable angina; history of myocardial infarction; history of percutaneous coronary intervention (PTCA with or without stent placement); coronary stenosis on angiography; history of unstable angina or non-Q wave myocardial infarction; history of coronary artery bypass graft surgery (CABG); positive MIBI scan. Patients have to be in a stable medical condition.

Exclusion Criteria:

* Patients in whom cholesterol lowering medication regime has changed in the previous 4 weeks.
* Patients who have been treated with any other investigational drug within 3 months of Visit 1.
* Patients who are pregnant or lactating.
* Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Answer: D