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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Hospital Arnau de Vilanova.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:
NCT00734123
First received: August 11, 2008
Last updated: August 13, 2008
Last verified: August 2008

August 11, 2008
August 13, 2008
April 2008
April 2009   (final data collection date for primary outcome measure)
Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734123 on ClinicalTrials.gov Archive Site
Cardio and cerebrovascular eventS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2948
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.
Both
40 Years to 74 Years
Yes
Contact: Blai Coll, MD,PhD +34 619633249 bcoll@arnau.scs.es
Spain
 
NCT00734123
UDETMA_08, UDETMA_2008_001
Yes
Elvira Fernandez, Hospital Arnau de Vilanova
Hospital Arnau de Vilanova
Pfizer
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