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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Hospital Arnau de Vilanova.
Recruitment status was:  Recruiting
Information provided by:
Hospital Arnau de Vilanova Identifier:
First received: August 11, 2008
Last updated: August 13, 2008
Last verified: August 2008
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 Intervention Phase
Cardiovascular Diseases
Drug: Simvastatin or Atorvastatin
Drug: Enalapril
Drug: Aspirin or clopidogrel
Drug: Rimonabant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Hospital Arnau de Vilanova:

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

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

Estimated Enrollment: 2948
Study Start Date: April 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00734123

Contact: Blai Coll, MD,PhD +34 619633249

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
Principal Investigator: Elvira Fernandez, MD,PhD Hospital Arnau de Vilanova
  More Information

Responsible Party: Elvira Fernandez, Hospital Arnau de Vilanova Identifier: NCT00734123     History of Changes
Other Study ID Numbers: UDETMA_08
Study First Received: August 11, 2008
Last Updated: August 13, 2008

Keywords provided by Hospital Arnau de Vilanova:
Cardiovascular Prevention
Carotid Intima-Media Thickness
Ankle-Brachial Index

Additional relevant MeSH terms:
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents processed this record on May 25, 2017