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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00734123
Recruitment Status : Unknown
Verified August 2008 by Hospital Arnau de Vilanova.
Recruitment status was:  Recruiting
First Posted : August 14, 2008
Last Update Posted : August 14, 2008
Information provided by:
Hospital Arnau de Vilanova

August 11, 2008
August 14, 2008
August 14, 2008
April 2008
April 2009   (Final data collection date for primary outcome measure)
Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ]
Same as current
No Changes Posted
Cardio and cerebrovascular eventS [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
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.
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.
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Atherosclerosis
  • Cardiovascular Diseases
  • Drug: Simvastatin or Atorvastatin
    Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.
    Other Names:
    • Simvastatin 10-40.
    • Atorvastatin 20-40.
  • Drug: Enalapril
    Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly
    Other Names:
    • ACE inhibitors.
    • ACE + diuretic
  • Drug: Aspirin or clopidogrel
    Aspirin 100 mg or clopidogrel 75 mg/ per day
    Other Name: Antiplatelets
  • Drug: 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

    Other Name: Rimonabant is allowed.
  • Experimental: 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.
    • Drug: Simvastatin or Atorvastatin
    • Drug: Enalapril
    • Drug: Aspirin or clopidogrel
    • Drug: Rimonabant
  • Active Comparator: 2
    Participants assigned to control group (2) will be followed according to the clinical standard of care.
    Intervention: Drug: Rimonabant
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2013
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 74 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Elvira Fernandez, Hospital Arnau de Vilanova
Hospital Arnau de Vilanova
Principal Investigator: Elvira Fernandez, MD,PhD Hospital Arnau de Vilanova
Hospital Arnau de Vilanova
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP