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

NCT ID: NCT00734123

Last Updated: 2008-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2948 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Atherosclerosis Cardiovascular Diseases

Keywords

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Atherosclerosis Cardiovascular Prevention Carotid Intima-Media Thickness Ankle-Brachial Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Simvastatin or Atorvastatin

Intervention Type DRUG

Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.

Enalapril

Intervention Type DRUG

Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly

Aspirin or clopidogrel

Intervention Type DRUG

Aspirin 100 mg or clopidogrel 75 mg/ per day

Rimonabant

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

Rimonabant

Intervention Type DRUG

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

Interventions

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Simvastatin or Atorvastatin

Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.

Intervention Type DRUG

Enalapril

Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly

Intervention Type DRUG

Aspirin or clopidogrel

Aspirin 100 mg or clopidogrel 75 mg/ per day

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Simvastatin 10-40. Atorvastatin 20-40. ACE inhibitors. ACE + diuretic Antiplatelets Rimonabant is allowed.

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Hospital Arnau de Vilanova

OTHER

Sponsor Role lead

Responsible Party

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Hospital Arnau de Vilanova

Principal Investigators

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Elvira Fernandez, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Arnau de Vilanova

Locations

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Hospital Arnau de Vilanova

Lleida, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Blai Coll, MD,PhD

Role: CONTACT

Phone: +34 619633249

Email: [email protected]

Facility Contacts

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Blai Coll, MD,PhD

Role: primary

Other Identifiers

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UDETMA_2008_001

Identifier Type: -

Identifier Source: secondary_id

UDETMA_08

Identifier Type: -

Identifier Source: org_study_id