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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00734123

Acronym

PRIMARIA

Enrollment

2948

Registered

2008-08-14

Start date

2008-04-30

Completion date

2013-05-31

Last updated

2008-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Cardiovascular Diseases

Keywords

Atherosclerosis, Cardiovascular Prevention, Carotid Intima-Media Thickness, Ankle-Brachial Index

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.

Interventions

DRUGSimvastatin or Atorvastatin

Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.

DRUGEnalapril

Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly

DRUGAspirin or clopidogrel

Aspirin 100 mg or clopidogrel 75 mg/ per day

DRUGRimonabant

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 74 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Carotid Intima-Media Thickness progression/regression	2 years

Secondary

Measure	Time frame
Cardio and cerebrovascular eventS	5 years

Countries

Spain

Contacts

Primary ContactBlai Coll, MD,PhD

bcoll@arnau.scs.es+34 619633249

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026