Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases. - Full Text View

Sponsor:	Hospital Arnau de Vilanova
Collaborator:	Pfizer
Information provided by:	Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:	NCT00734123

Purpose

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
Atherosclerosis Cardiovascular Diseases	Drug: Simvastatin or Atorvastatin Drug: Enalapril Drug: Aspirin or clopidogrel Drug: Rimonabant	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

Drug Information available for: Acetylsalicylic acid Enalapril Enalapril maleate Enalaprilat Simvastatin Clopidogrel Clopidogrel Bisulfate Atorvastatin Atorvastatin calcium SR 141716A Rimonabant

U.S. FDA Resources

Further study details as provided by Hospital Arnau de Vilanova:

Primary Outcome Measures:

Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardio and cerebrovascular eventS [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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
1: Experimental 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. Drug: Enalapril Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly Drug: Aspirin or clopidogrel Aspirin 100 mg or clopidogrel 75 mg/ per day 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
2: Active Comparator 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

Arms

Assigned Interventions

1: Experimental

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.

Drug: Enalapril

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

Drug: Aspirin or clopidogrel

Aspirin 100 mg or clopidogrel 75 mg/ per day

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

2: Active Comparator

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

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.

Eligibility

Ages Eligible for Study:	40 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734123

Contacts

Contact: Blai Coll, MD,PhD

+34 619633249

bcoll@arnau.scs.es

Locations

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

Sponsors and Collaborators

Hospital Arnau de Vilanova

Pfizer

Investigators

Principal Investigator:

Elvira Fernandez, MD,PhD

Hospital Arnau de Vilanova

More Information

No publications provided

Responsible Party:	Hospital Arnau de Vilanova ( Elvira Fernandez )
Study ID Numbers:	UDETMA_08, UDETMA_2008_001
Study First Received:	August 11, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00734123 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Arnau de Vilanova:

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

Additional relevant MeSH terms:

Antimetabolites
Atherosclerosis
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Arteriosclerosis
Enalapril
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal

Cardiovascular Diseases
Analgesics
Arterial Occlusive Diseases
Simvastatin
Antilipemic Agents
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 08, 2010