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

Primary Purpose

Atherosclerosis, Cardiovascular Diseases

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Simvastatin or Atorvastatin
Enalapril
Aspirin or clopidogrel
Rimonabant
Sponsored by
Hospital Arnau de Vilanova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring Atherosclerosis, Cardiovascular Prevention, Carotid Intima-Media Thickness, Ankle-Brachial Index

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Arnau de VilanovaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Carotid Intima-Media Thickness progression/regression

Secondary Outcome Measures

Cardio and cerebrovascular eventS

Full Information

First Posted
August 11, 2008
Last Updated
August 13, 2008
Sponsor
Hospital Arnau de Vilanova
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00734123
Brief Title
Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
Acronym
PRIMARIA
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 Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Arnau de Vilanova
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Cardiovascular Diseases
Keywords
Atherosclerosis, Cardiovascular Prevention, Carotid Intima-Media Thickness, Ankle-Brachial Index

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2948 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants assigned to control group (2) will be followed according to the clinical standard of care.
Intervention Type
Drug
Intervention Name(s)
Simvastatin or Atorvastatin
Other Intervention Name(s)
Simvastatin 10-40., Atorvastatin 20-40.
Intervention Description
Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.
Intervention Type
Drug
Intervention Name(s)
Enalapril
Other Intervention Name(s)
ACE inhibitors., ACE + diuretic
Intervention Description
Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly
Intervention Type
Drug
Intervention Name(s)
Aspirin or clopidogrel
Other Intervention Name(s)
Antiplatelets
Intervention Description
Aspirin 100 mg or clopidogrel 75 mg/ per day
Intervention Type
Drug
Intervention Name(s)
Rimonabant
Other Intervention Name(s)
Rimonabant is allowed.
Intervention Description
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
Primary Outcome Measure Information:
Title
Carotid Intima-Media Thickness progression/regression
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Cardio and cerebrovascular eventS
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blai Coll, MD,PhD
Phone
+34 619633249
Email
bcoll@arnau.scs.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elvira Fernandez, MD,PhD
Organizational Affiliation
Hospital Arnau de Vilanova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Arnau de Vilanova
City
Lleida
State/Province
Catalunya
ZIP/Postal Code
25260
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blai Coll, MD,PhD
Phone
+34 619633249
Email
bcoll@arnau.scs.es
First Name & Middle Initial & Last Name & Degree
Blai Coll, MD,PhD
First Name & Middle Initial & Last Name & Degree
Merce Borras, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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