NCT00734123

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,948

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 14, 2008

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

August 11, 2008

Last Update Submit

August 13, 2008

Conditions

AtherosclerosisCardiovascular Diseases

Keywords

AtherosclerosisCardiovascular PreventionCarotid Intima-Media ThicknessAnkle-Brachial Index

Outcome Measures

Primary Outcomes (1)

  • Carotid Intima-Media Thickness progression/regression

    2 years

Secondary Outcomes (1)

  • Cardio and cerebrovascular eventS

    5 years

Study Arms (2)

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 AtorvastatinDrug: EnalaprilDrug: Aspirin or clopidogrelDrug: Rimonabant

2

ACTIVE COMPARATOR

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

Drug: Rimonabant

Interventions

Simvastatin or AtorvastatinDRUG

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

Also known as: Simvastatin 10-40., Atorvastatin 20-40.
1
EnalaprilDRUG

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

Also known as: ACE inhibitors., ACE + diuretic
1
Aspirin or clopidogrelDRUG

Aspirin 100 mg or clopidogrel 75 mg/ per day

Also known as: Antiplatelets
1
RimonabantDRUG

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

Also known as: Rimonabant is allowed.
12

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 40 or \> 74 years old.
  • Previous Cardiovascular Event.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Arnau de Vilanova

Lleida, Catalonia, 25260, Spain

RECRUITING

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Interventions

SimvastatinAtorvastatinEnalaprilAngiotensin-Converting Enzyme InhibitorsDiureticsAspirinClopidogrelRimonabant

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNatriuretic AgentsPhysiological Effects of DrugsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPyrazolesPiperidines

Study Officials

  • Elvira Fernandez, MD,PhD

    Hospital Arnau de Vilanova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Blai Coll, MD,PhD

CONTACT

+34 619633249bcoll@arnau.scs.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 14, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

May 1, 2013

Last Updated

August 14, 2008

Record last verified: 2008-08

Locations

ES(1)