Vytorin on Carotid Intima-media Thickness and Overall Rigidity

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe (+) simvastatin

Drug

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

Other names: MK0653A, Vytorin

simvastatin

Drug

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

Other names: Zocor

Pravastatin

Drug

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

Primary outcomes

The annual progression of the slope of the maximum average GIM and the arterial rigidity.

Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Acronym: VYCTOR

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Aug 20, 2008
Registry last updated: Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed