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

• ClinicalTrials.gov Identifier: NCT00734123
• Recruitment Status: Unknown
• First Posted: August 14, 2008
• Last Update Posted: August 14, 2008
• Sponsor: Hospital Arnau de Vilanova
• Collaborator: Pfizer
• Information provided by: Hospital Arnau de Vilanova

Tracking Information

• First Submitted Date: August 11, 2008
• First Posted Date: August 14, 2008
• Last Update Posted Date: August 14, 2008
• Study Start Date: April 2008
• Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 13, 2008): Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: August 13, 2008): Cardio and cerebrovascular eventS [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
• 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.
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• 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.
  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

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 13, 2008): 2948
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2013
• Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 40 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT00734123
• Other Study ID Numbers: UDETMA_08; UDETMA_2008_001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Elvira Fernandez, Hospital Arnau de Vilanova
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Arnau de Vilanova
• Original Study Sponsor: Same as current
• Collaborators: Pfizer

Investigators

• Principal Investigator: Elvira Fernandez, MD,PhD; Hospital Arnau de Vilanova

• PRS Account: Hospital Arnau de Vilanova
• Verification Date: August 2008