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.
Overview
- Phase
- Phase 4
- Intervention
- Simvastatin or Atorvastatin
- Conditions
- Atherosclerosis
- Sponsor
- Hospital Arnau de Vilanova
- Enrollment
- 2948
- Locations
- 1
- Primary Endpoint
- Carotid Intima-Media Thickness progression/regression
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Age \< 40 or \> 74 years old.
- •Previous Cardiovascular Event.
Arms & Interventions
1
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.
Intervention: Simvastatin or Atorvastatin
1
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.
Intervention: Enalapril
1
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.
Intervention: Aspirin or clopidogrel
1
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.
Intervention: Rimonabant
2
Participants assigned to control group (2) will be followed according to the clinical standard of care.
Intervention: Rimonabant
Outcomes
Primary Outcomes
Carotid Intima-Media Thickness progression/regression
Time Frame: 2 years
Secondary Outcomes
- Cardio and cerebrovascular eventS(5 years)