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

Cardiovascular Diseases Clinical Trial

— PRIMARIA  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00734123
• Other study ID #: UDETMA_08
• Secondary ID: UDETMA_2008_001
• Status: Recruiting
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: August 13, 2008
• Start date: April 2008
• Est. completion date: May 2013

Study information

• Verified date: August 2008
• Source: Hospital Arnau de Vilanova
• Contact: Blai Coll, MD,PhD
• Phone: +34 619633249
• Email: bcoll[@]arnau.scs.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2948
• Est. completion date: May 2013
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases

Intervention

Drug:
• Simvastatin or Atorvastatin
Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.
• Enalapril
Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly
• Aspirin or clopidogrel
Aspirin 100 mg or clopidogrel 75 mg/ per day
• Rimonabant
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

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova	Lleida	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid Intima-Media Thickness progression/regression		2 years	No
Secondary	Cardio and cerebrovascular eventS		5 years	No