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

Hospital Arnau de Vilanova

Status and phase: Unknown; Phase 4

Conditions: Cardiovascular Diseases; Atherosclerosis

Treatments: Drug: Aspirin or clopidogrel; Drug: Rimonabant; Drug: Simvastatin or Atorvastatin; Drug: Enalapril

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00734123

UDETMA_2008_001

UDETMA_08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,948 estimated patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,948 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Drug: Enalapril

Drug: Simvastatin or Atorvastatin

Drug: Rimonabant

Drug: Aspirin or clopidogrel

2

Active Comparator group

Description:

Participants assigned to control group (2) will be followed according to the clinical standard of care.

Treatment:

Drug: Rimonabant