Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Options:
A: 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.
B: Inclusion Criteria:

* Men and women aged 45 and older with established vascular disease and atherogenic dyslipidemia
* Established vascular disease defined as one or more of the following: (1) documented coronary artery disease (CAD); (2) documented cerebrovascular or carotid disease; (3) documented symptomatic peripheral arterial disease (PAD)
* Atherogenic dyslipidemia defined as: (1) LDL-C of less than or equal to 160 mg/dL (4.1 mmol/L); (2) HDL-C of less than or equal to 40 mg/dL (1.0 mmol/L) for men or less than or equal to 50 mg/dL (1.3 mmol/L) for women; (3) TG greater than or equal to 150 mg/dL (1.7 mmol/L) and less than or equal to 400 mg/dL (4.5 mmol/L)
* For patients entering the trial on a statin: (1) the upper limit for LDL-C is adjusted according to the specific statin and statin dose; (2) HDL-C of less than or equal to 42 mg/dL (1.1 mmol/L) for men or less than or equal to 53 mg/dL (1.4 mmol/L) for women; (3) TG greater than or equal to 125 mg/dL (1.4 mmol/L) and less than or equal to 400 mg/DL (4.5 mmol/L)

Exclusion Criteria:

* Coronary artery bypass graft (CABG) surgery within 1 year of planned enrollment (run-in phase)
* Percutaneous coronary intervention (PCI) within 4 weeks of planned enrollment (run-in phase)
* Hospitalization for acute coronary syndrome and discharge within 4 weeks of planned enrollment (run-in phase)
* Fasting glucose greater than 180 mg/dL (10 mmol/L) or hemoglobin A1C greater than 9%
* For patients with diabetes, inability or refusal to use a glucometer for home monitoring of blood glucose
* Concomitant use of drugs with a high probability of increasing the risk for hepatotoxicity or myopathy, such as those predominantly metabolized by cytochrome P450 system 3A4, including but not limited to cyclosporine, gemfibrozil, fenofibrate, itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, verapamil, amiodarone; lipid-lowering drugs (other than the investigational drugs) such as statins, bile-acid sequestrants, cholesterol absorption inhibitors (e.g., ezetimibe), fibrates or high-dose, antioxidant vitamins (vitamins C, E, or beta carotene) that can interfere with the HDL-raising effect of niacin
C: Inclusion Criteria:

* Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
* LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides \</= 350 mg/dL.

Exclusion Criteria:

* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
* Patients with \<80% compliance
* Patients with certain medical conditions
* Patients taking certain concomitant medications and/or with unstable doses of medications
* Or those with a history of CHD/CHD equivalent or diabetes
D: Inclusion Criteria:

1. Age 18 years or greater
2. Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
3. Undergoing clinically-indicated coronary and SVG angiography
4. Have an intermediate SVG lesion (defined as a lesion 30-60% angiographic diameter stenosis) without previous percutaneous intervention, amenable to examination with IVUS. The lesion should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for graft angiography.

Exclusion Criteria:

1. Known allergy to niacin
2. History of statin-induced myopathy
3. Positive pregnancy test or breast-feeding
4. Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
5. Uncontrolled fasting triglyceride levels ( 500 mg/dL)
6. Fasting LDL-C \>200 mg/dL
7. Fasting HDL-C \>60 mg/dL
8. Poorly controlled diabetes (glycosylated hemoglobin levels 10%)
9. Current active liver disease or hepatic dysfunction
10. AST or ALT \> 2x the upper limit of normal
11. Uncontrolled hypothyroidism (Thyroid Stimulating Hormone \>1.5 x upper limit of normal \[ULN\])
12. Unexplained creatine kinase elevations (\>3 x ULN)
13. Recent history of acute gout
14. Serum creatinine \> 2.5 mg/dL
15. HIV (due to potential anti-retroviral drug-interactions with niacin)
16. Use of high-dose, antioxidant vitamins (vitamins C, E, or beta-carotene) that may interfere with the HDL-raising effect of niacin
17. Severe peripheral arterial disease limiting vascular access
18. Referral for cardiac catheterization by a physician who is an investigator in the present study.
19. Symptoms consistent with moderate or greater severity of congestive heart failure (New York Heart Association - NYHA class III or IV) or whose most recent determination of left ventricular ejection fraction is \<25%
20. Uncontrolled hypertension, defined as either a resting diastolic blood pressure of ≥100 mmHg or a resting systolic blood pressure of ≥200 mmHg
21. History of allergic reaction to iodine-based contrast agents
22. Significant medical or psychological condition that, in the opinion of the investigator, may compromise the patient's safety or successful participation in the study

Answer: A