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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Atherosclerosis, Cardiovascular Diseases

Intervention / Treatment
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* Drug: Simvastatin or Atorvastatin
* Drug: Enalapril
* Drug: Aspirin or clopidogrel
* Drug: Rimonabant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria One or more of the following: Familiar History of early-onset cardiovascular disease (male < 55 or female < 65). Type 2 Diabetes mellitus or type 1 with microalbuminuria. Essential High Blood Pressure. Chronic Kidney Disease. Primary hyperlipidemia. The presence of two or more of the following: Current smoker. Physical inactivity. High blood pressure (recently diagnosed). Abdominal perimeter: > 102 cm. males; > 88 cm. females. Total cholesterol > 240 mg/dL. HDL cholesterol ≤ 40 mg/dL males, ≤ 50 mg/dL females. Exclusion Criteria: Age < 40 or > 74 years old. Previous Cardiovascular Event.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: Simvastatin or Atorvastatin<br>* Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.<br>* Other names: Atorvastatin 20-40.;Drug: Enalapril<br>* Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly<br>* Other names: ACE + diuretic;Drug: Aspirin or clopidogrel<br>* Aspirin 100 mg or clopidogrel 75 mg/ per day<br>* Other names: Antiplatelets;Drug: Rimonabant<br>* 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<br>* Other names: Rimonabant is allowed.;|
| Active Comparator: 2<br>Participants assigned to control group (2) will be followed according to the clinical standard of care. | Drug: Rimonabant<br>* 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<br>* Other names: Rimonabant is allowed.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid Intima-Media Thickness progression/regression |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio and cerebrovascular eventS |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Cardiovascular Prevention, Carotid Intima-Media Thickness, Ankle-Brachial Index