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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

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Cardiovascular Diseases Drug: Simvastatin or Atorvastatin Drug: Enalapril Drug: Aspirin or clopidogrel Drug: Rimonabant Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2948 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Study Start Date : April 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
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
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.

Active Comparator: 2
Participants assigned to control group (2) will be followed according to the clinical standard of care.
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.

Primary Outcome Measures :
  1. Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cardio and cerebrovascular eventS [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00734123

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Contact: Blai Coll, MD,PhD +34 619633249

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Hospital Arnau de Vilanova Recruiting
Lleida, Catalunya, Spain, 25260
Contact: Blai Coll, MD,PhD    +34 619633249   
Sub-Investigator: Blai Coll, MD,PhD         
Sub-Investigator: Merce Borras, MD,PhD         
Sponsors and Collaborators
Hospital Arnau de Vilanova
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Principal Investigator: Elvira Fernandez, MD,PhD Hospital Arnau de Vilanova

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Responsible Party: Elvira Fernandez, Hospital Arnau de Vilanova Identifier: NCT00734123    
Other Study ID Numbers: UDETMA_08
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008
Keywords provided by Hospital Arnau de Vilanova:
Cardiovascular Prevention
Carotid Intima-Media Thickness
Ankle-Brachial Index
Additional relevant MeSH terms:
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Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents