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

Sponsor:

Collaborator:

Pfizer

Information provided by:

Hospital Arnau de Vilanova

ClinicalTrials.gov Identifier:

NCT00734123

First received: August 11, 2008

Last updated: August 13, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 11, 2008

Last Updated Date

August 13, 2008

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

April 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Cardio and cerebrovascular eventS [ Time Frame: 5 years ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Atherosclerosis
Cardiovascular Diseases

Intervention ^ICMJE

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

2948

Estimated Completion Date

May 2013

Estimated Primary Completion Date

April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00734123

Other Study ID Numbers ^ICMJE

UDETMA_08
UDETMA_2008_001

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Elvira Fernandez, Hospital Arnau de Vilanova

Study Sponsor ^ICMJE

Hospital Arnau de Vilanova

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Principal Investigator:

Elvira Fernandez, MD,PhD

Hospital Arnau de Vilanova

PRS Account

Hospital Arnau de Vilanova

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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