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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Atherosclerosis
• Intervention / Treatment: Drug: Simvastatin or Atorvastatin; Drug: Enalapril; Drug: Aspirin or clopidogrel; Drug: Rimonabant

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
• Enrollment (Anticipated): 2948
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Blai Coll, MD,PhD; Phone Number: +34 619633249; Email: bcoll@arnau.scs.es

Study Locations

• Spain
  • Catalunya
    • Lleida, Catalunya, Spain, 25260
      • Recruiting
      • Hospital Arnau de Vilanova
      • Contact: Blai Coll, MD,PhD; Phone Number: +34 619633249; Email: bcoll@arnau.scs.es
      • Sub-Investigator: Blai Coll, MD,PhD
      • Sub-Investigator: Merce Borras, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Rimonabant is allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carotid Intima-Media Thickness progression/regression	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardio and cerebrovascular eventS	5 years

Collaborators and Investigators

• Sponsor: Hospital Arnau de Vilanova
• Collaborators: Pfizer
• Investigators: Principal Investigator: Elvira Fernandez, MD,PhD, Hospital Arnau de Vilanova

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Anticipated): April 1, 2009
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Estimate): August 14, 2008
• Last Update Submitted That Met QC Criteria: August 13, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Atherosclerosis; Carotid Intima-Media Thickness; Ankle-Brachial Index; Cardiovascular Prevention
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Antimetabolites; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Natriuretic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anti-Obesity Agents; Cannabinoid Receptor Modulators; Cannabinoid Receptor Antagonists; Aspirin; Atorvastatin; Clopidogrel; Enalapril; Simvastatin; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Rimonabant
• Other Study ID Numbers: UDETMA_08; UDETMA_2008_001