NCT00734123

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

Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,948 (estimated)
• Sponsor: Hospital Arnau de Vilanova · Academic / Other
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed description

We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk.With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up.

Conditions

• Atherosclerosis
• Cardiovascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-04-01
• Completion: 2013-05-01
• First posted: 2008-08-14
• Last updated: 2008-08-14

Locations

1 site across 1 country: Spain