Effects in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome

December 12, 2007 updated by: AstraZeneca

Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS

The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.

Study Overview

Status

Completed

Conditions

Acute Coronary Syndrome

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1160

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Aalst, Belgium
    - Research Site
  - Bonheiden, Belgium
    - Research Site
  - Bouge, Belgium
    - Research Site
  - Brussels, Belgium
    - Research Site
  - Charleroi, Belgium
    - Research Site
  - Hasselt, Belgium
    - Research Site
  - Huy, Belgium
    - Research Site
  - La Louviere, Belgium
    - Research Site
  - Leuven, Belgium
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada
    - Research Site
  - Victoria, British Columbia, Canada
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada
    - Research Site
- New Brunswick
  - Saint John, New Brunswick, Canada
    - Research Site
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada
    - Research Site
- Ontario
  - Kingston, Ontario, Canada
    - Research Site
  - London, Ontario, Canada
    - Research Site
  - Scarborough, Ontario, Canada
    - Research Site
  - Toronto, Ontario, Canada
    - Research Site
- Quebec
  - Laval, Quebec, Canada
    - Research Site
  - Montreal, Quebec, Canada
    - Research Site
  - Pointe-claire, Quebec, Canada
    - Research Site
  - Saint-charles-borromee, Quebec, Canada
    - Research Site
  - Sherbrooke, Quebec, Canada
    - Research Site
- Saskatchewan
  - Regina, Saskatchewan, Canada
    - Research Site
Estonia
- - Tallinn, Estonia
    - Research Site
  - Tartu, Estonia
    - Research Site
France
- - Amiens, France
    - Research Site
  - Annecy, France
    - Research Site
  - Arras, France
    - Research Site
  - Avignon, France
    - Research Site
  - Boulogne Billancourt, France
    - Research Site
  - Caen, France
    - Research Site
  - Cholet, France
    - Research Site
  - Creteil, France
    - Research Site
  - Dijon, France
    - Research Site
  - Eaubonne, France
    - Research Site
  - Evecquemont, France
    - Research Site
  - Falaise, France
    - Research Site
  - LAGNY sur MARNE, France
    - Research Site
  - La Roche Sur Yon, France
    - Research Site
  - Le Coudray, France
    - Research Site
  - Le Mans, France
    - Research Site
  - Lille, France
    - Research Site
  - Marseille, France
    - Research Site
  - Metz, France
    - Research Site
  - Montpellier, France
    - Research Site
  - Nevers, France
    - Research Site
  - PAU, France
    - Research Site
  - Paris, France
    - Research Site
  - Pessac, France
    - Research Site
  - Reims, France
    - Research Site
  - Rouen, France
    - Research Site
  - Saint-Herblain, France
    - Research Site
  - Suresnes, France
    - Research Site
  - Toulouse, France
    - Research Site
  - Tourcoing, France
    - Research Site
  - Tours, France
    - Research Site
  - Valenciennes, France
    - Research Site
  - Vannes, France
    - Research Site
  - Villeurbanne, France
    - Research Site
Greece
- - Athens, Greece
    - Research Site
Hungary
- - Balatonfüred, Hungary
    - Research Site
  - Budapest, Hungary
    - Research Site
  - Pecs, Hungary
    - Research Site
  - Zalaegerszeg, Hungary
    - Research Site
Ireland
- - Dublin, Ireland
    - Research Site
  - Galway, Ireland
    - Research Site
  - Limerick, Ireland
    - Research Site
Italy
- - Bolzano, Italy
    - Research Site
  - Napoli, Italy
    - Research Site
  - Padova, Italy
    - Research Site
  - Roma, Italy
    - Research Site
- Basilicata
  - Cosenza, Basilicata, Italy
    - Research Site
- Campania
  - Benevento, Campania, Italy
    - Research Site
- Lombardia
  - Mantova, Lombardia, Italy
    - Research Site
  - Rozzano (Milano), Lombardia, Italy
    - Research Site
- Puglia
  - Bari, Puglia, Italy
    - Research Site
- Sicilia
  - Catania, Sicilia, Italy
    - Research Site
- Toscana
  - Pisa, Toscana, Italy
    - Research Site
- Umbria
  - Perugia, Umbria, Italy
    - Research Site
- Veneto
  - Verona, Veneto, Italy
    - Research Site
Portugal
- - Aveiro, Portugal
    - Research Site
  - Braga, Portugal
    - Research Site
  - Carnaxide, Portugal
    - Research Site
  - Faro, Portugal
    - Research Site
  - Funchal, Portugal
    - Research Site
  - Leiria, Portugal
    - Research Site
  - Vila Real, Portugal
    - Research Site
Spain
- - Madrid, Spain
    - Research Site
  - Sevilla, Spain
    - Research Site
- Aragón
  - Zaragoza, Aragón, Spain
    - Research Site
- Castilla la Mancha
  - Toledo, Castilla la Mancha, Spain
    - Research Site
- Cataluña
  - Tarragona, Cataluña, Spain
    - Research Site
- Comunidad Valenciana
  - San Juan de Alicante, Comunidad Valenciana, Spain
    - Research Site
- Madrid
  - Fuenlabrada(Madrid), Madrid, Spain
    - Research Site
- Pontevedra
  - Vigo, Pontevedra, Spain
    - Research Site
Tunisia
- - Bab Saâdoun Tunis, Tunisia
    - Research Site
  - Sidi Daoud Tunis, Tunisia
    - Research Site
  - Sousse, Tunisia
    - Research Site
  - Tunis, Tunisia
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion,
Percutaneous coronary intervention (PCI) planned,
Evidence of coronary artery disease

Exclusion Criteria:

Hypersensitivity to statins
Any cholesterol lowering medication taken within 1 month prior V1
Sustained ST-segment elevation on ECG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage changes in ApoB/ApoA-I levels Time Frame: from Day 0 to 3 months	from Day 0 to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage changes in LDL-C Time Frame: from Day 0 to 1 month and 3 months	from Day 0 to 1 month and 3 months
Percentage changes in the hs-CRP and AUC of hs-CRP levels Time Frame: from Day -6 to Day 0	from Day -6 to Day 0
Percentage changes in ApoA-I Time Frame: from Day 0 to 1 month	from Day 0 to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lablanche JM, Leone A, Merkely B, Morais J, Alonso J, Santini M, Eha J, Demil N, Licour M, Tardif JC; CENTAURUS investigators. Comparison of the efficacy of rosuvastatin versus atorvastatin in reducing apolipoprotein B/apolipoprotein A-1 ratio in patients with acute coronary syndrome: results of the CENTAURUS study. Arch Cardiovasc Dis. 2010 Mar;103(3):160-9. doi: 10.1016/j.acvd.2010.01.005. Epub 2010 Apr 8.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria