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Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.

NCT00734123 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2948

Last updated 2008-08-14

No results posted yet for this study

Summary

The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.

Conditions

Interventions

DRUG

Simvastatin or Atorvastatin

Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.

DRUG

Enalapril

Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly

DRUG

Aspirin or clopidogrel

Aspirin 100 mg or clopidogrel 75 mg/ per day

DRUG

Rimonabant

In both arms, we will follow the standard clinical care in terms of treatments, as far as obesity and diabetes mellitus is concerned. Drugs will be prescribed as the standard clinical care

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hospital Arnau de Vilanova

    lead OTHER

Principal Investigators

  • Elvira Fernandez, MD,PhD · Hospital Arnau de Vilanova

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-04-30
Completion
2013-05-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734123 on ClinicalTrials.gov