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

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ClinicalTrials.gov 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

Tracking Information
First Submitted Date  ICMJE August 11, 2008
First Posted Date  ICMJE August 14, 2008
Last Update Posted Date August 14, 2008
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
Cardio and cerebrovascular eventS [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atherosclerosis
  • Cardiovascular Diseases
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 13, 2008)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2013
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00734123
Other Study ID Numbers  ICMJE UDETMA_08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Elvira Fernandez, Hospital Arnau de Vilanova
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospital Arnau de Vilanova
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Elvira Fernandez, MD,PhD Hospital Arnau de Vilanova
PRS Account Hospital Arnau de Vilanova
Verification Date August 2008

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