Vytorin on Carotid Intima-media Thickness and Overall Rigidity (VYCTOR)

Madrid Health Service

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Diseases

Treatments: Drug: simvastatin; Drug: ezetimibe (+) simvastatin; Drug: pravastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00738296

2008_018

MK0653A-164

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

A

Active Comparator group

Description:

Group A: Comparator

Treatment:

Drug: simvastatin

B

Active Comparator group

Description:

Group B: Comparator

Treatment:

Drug: pravastatin

C

Experimental group

Description:

Group C: Drug

Treatment:

Drug: ezetimibe (+) simvastatin