Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol.
Brief Summary: The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.


Options:
A: Inclusion Criteria:

* Visit 1:

  1. Written informed consent to participate in the trial (Appendix B)
  2. Male or female subjects, age \> 18 years
  3. Primary hypercholesterolaemia with CV risk \> 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L).
  4. Subjects may be lipid-lowering therapy-naïve, but have completed 6-weeks dietary counselling before this visit OR Subjects may be treated with the 'start' dose of other lipid lowering therapy, which is ineffective, ie. The subject has not met LDL-C treatment goals.
  5. Subjects willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen

     Visit 2:
  6. Subjects switched from start dose of a lipid lowering therapy (commonly accepted start dose) will have fasting LDL-C levels \> 3.1 mmol (120 mg/dl)
  7. Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels \> 3.5 mmol/L (135 mg/dL)
  8. Fasting triglycerides £ 4.52 mmol/L (400 mg/dL)
  9. Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)

Exclusion Criteria:

1. Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
2. Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3
3. History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
4. Unstable angina within three months prior to inclusion in the study
5. Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT ³ 1.5 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
6. Known uncontrolled diabetes
7. Uncontrolled hypertension defined as either resting diastolic blood pressure of \> 95mmHg or resting systolic blood pressure of \> 200 mmHg
8. Unexplained serum CK \> 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc)
9. Serum creatinine \> 220 µmol/L (2.5mg/dL)
B: Inclusion Criteria:

* Subjects with mixed dyslipidemia
* Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

Exclusion Criteria:

* Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
* Patients who are taking certain medications or unstable dose of specific medications.
* Women who are pregnant or plan on becoming pregnant, or women who are lactating.
C: Inclusion Criteria:

* Mild to moderate AS defined by peak Doppler aortic valve velocity 2.5 to 4 m/sec
* Baseline LDL-C value must be within targeted level for all risk categories according to the Canadian Guidelines
* Baseline triglyceride levels must be within target level for the risk categories

Exclusion Criteria:

* Very mild AS defined by peak Doppler AS velocity \<2.5m/sec, because the rate of progression is not well defined; Females of child bearing potential who do not practice adequate contraception.
* Severe AS defined by peak Doppler AS velocity \> 4m/sec. These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression.
* Greater than moderate aortic regurgitation, defined as aortic jet width to aortic outflow tract ratio \>0.45; Patients with diabetes or with a fasting blood sugar level \> 7.0 mmol/L (must be confirmed with one repeat assay within 14 days).
* Significant concomitant mitral valve disease, defined by \> moderate mitral regurgitation (MR) or mitral valve area (MVA)\< 1.5 cm2; A very high risk of CAD (10 year risk \> 30%), according to the Canadian Guidelines.
D: Inclusion Criteria:

* Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy

Exclusion Criteria:

* Previous Q-wave infarct within the last 4 weeks
* CK elevation not caused by myocardial injury
* uncontrolled hypertension at time of randomization

Answer: C