Cardiovascular Diseases
Conditions
Brief summary
Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level \> 100 mg/dL, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year.
Interventions
Patients will receive the combination of ezetimibe/simvastatin 10/20 mg o.d. with the possibility to increase the dose to 10/40 mg o.d. for 1 year. Tablets
DRUGsimvastatin
Patients will receive 40mg od. With the possibility to escalate the dose to 80 mg o.d. if therapeutic goals not attained; for 1 year. Tablets
DRUGpravastatin
Patients will receive pravastatin 40 mg o.d. with the possibility to add up 10mg of ezetimibe daily if LDL-C goal is not achieved; for 1 year. Tablets
Sponsors
Merck Sharp & Dohme LLC
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ldl-C Levels \>100 Mg/Dl * Patients Who Have Signed The Consent * Patients Of ages between 30 and 75 Years Old * Patients Of Both Genders * Patients With Established Cardiovascular Disease, Diabetes With Or Without Established Cardiovascular Disease * Patients Without Previous Treatment With Ezetimibe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annual progression of the slope of the maximum average GIM and the arterial rigidity. | 1 Year |
Outcome results
None listed