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

Phase 4

• Conditions: Atherosclerosis; Cardiovascular Diseases
• Interventions: Drug: Simvastatin or Atorvastatin; Drug: Enalapril; Drug: Aspirin or clopidogrel; Drug: Rimonabant

• Registration Number: NCT00734123
• Lead Sponsor: Hospital Arnau de Vilanova

Brief 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.

Study Timeline

• Study Start: 2008-04
• Status Verified: 2008-08
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-13
• Last Update Submitted: 2008-08-13
• Study First Posted: 2008-08-14
• Last Update Posted: 2008-08-14
• Primary Completion: 2009-04
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2948

Inclusion Criteria

Not provided

Exclusion Criteria

• Age < 40 or > 74 years old.
• Previous Cardiovascular Event.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Simvastatin or Atorvastatin	Participants assigned to the intensive arm (1) will be targeted to specified therapeutic aims (concerning lipids, blood pressure and antiplatelets)according to the results of carotid ultrasound and ankle-brachial index.
1	Enalapril	Participants assigned to the intensive arm (1) will be targeted to specified therapeutic aims (concerning lipids, blood pressure and antiplatelets)according to the results of carotid ultrasound and ankle-brachial index.
1	Aspirin or clopidogrel	Participants assigned to the intensive arm (1) will be targeted to specified therapeutic aims (concerning lipids, blood pressure and antiplatelets)according to the results of carotid ultrasound and ankle-brachial index.
1	Rimonabant	Participants assigned to the intensive arm (1) will be targeted to specified therapeutic aims (concerning lipids, blood pressure and antiplatelets)according to the results of carotid ultrasound and ankle-brachial index.
2	Rimonabant	Participants assigned to control group (2) will be followed according to the clinical standard of care.

Primary Outcome Measures

Name	Time	Method
Carotid Intima-Media Thickness progression/regression	2 years

Secondary Outcome Measures

Name	Time	Method
Cardio and cerebrovascular eventS	5 years

Trial Locations

Locations (1)

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Catalunya, Spain