search
Back to results

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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

Percentage changes in ApoB/ApoA-I levels

Secondary Outcome Measures

Percentage changes in LDL-C
Percentage changes in the hs-CRP and AUC of hs-CRP levels
Percentage changes in ApoA-I

Full Information

First Posted
February 23, 2006
Last Updated
December 12, 2007
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00296387
Brief Title
Effects in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome
Official Title
Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1160 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Percentage changes in ApoB/ApoA-I levels
Time Frame
from Day 0 to 3 months
Secondary Outcome Measure Information:
Title
Percentage changes in LDL-C
Time Frame
from Day 0 to 1 month and 3 months
Title
Percentage changes in the hs-CRP and AUC of hs-CRP levels
Time Frame
from Day -6 to Day 0
Title
Percentage changes in ApoA-I
Time Frame
from Day 0 to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca France Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aalst
Country
Belgium
Facility Name
Research Site
City
Bonheiden
Country
Belgium
Facility Name
Research Site
City
Bouge
Country
Belgium
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Charleroi
Country
Belgium
Facility Name
Research Site
City
Hasselt
Country
Belgium
Facility Name
Research Site
City
Huy
Country
Belgium
Facility Name
Research Site
City
La Louviere
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Pointe-claire
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saint-charles-borromee
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
Research Site
City
Tartu
Country
Estonia
Facility Name
Research Site
City
Amiens
Country
France
Facility Name
Research Site
City
Annecy
Country
France
Facility Name
Research Site
City
Arras
Country
France
Facility Name
Research Site
City
Avignon
Country
France
Facility Name
Research Site
City
Boulogne Billancourt
Country
France
Facility Name
Research Site
City
Caen
Country
France
Facility Name
Research Site
City
Cholet
Country
France
Facility Name
Research Site
City
Creteil
Country
France
Facility Name
Research Site
City
Dijon
Country
France
Facility Name
Research Site
City
Eaubonne
Country
France
Facility Name
Research Site
City
Evecquemont
Country
France
Facility Name
Research Site
City
Falaise
Country
France
Facility Name
Research Site
City
La Roche Sur Yon
Country
France
Facility Name
Research Site
City
LAGNY sur MARNE
Country
France
Facility Name
Research Site
City
Le Coudray
Country
France
Facility Name
Research Site
City
Le Mans
Country
France
Facility Name
Research Site
City
Lille
Country
France
Facility Name
Research Site
City
Marseille
Country
France
Facility Name
Research Site
City
Metz
Country
France
Facility Name
Research Site
City
Montpellier
Country
France
Facility Name
Research Site
City
Nevers
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
PAU
Country
France
Facility Name
Research Site
City
Pessac
Country
France
Facility Name
Research Site
City
Reims
Country
France
Facility Name
Research Site
City
Rouen
Country
France
Facility Name
Research Site
City
Saint-Herblain
Country
France
Facility Name
Research Site
City
Suresnes
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Tourcoing
Country
France
Facility Name
Research Site
City
Tours
Country
France
Facility Name
Research Site
City
Valenciennes
Country
France
Facility Name
Research Site
City
Vannes
Country
France
Facility Name
Research Site
City
Villeurbanne
Country
France
Facility Name
Research Site
City
Athens
Country
Greece
Facility Name
Research Site
City
Balatonfüred
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Pecs
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Research Site
City
Dublin
Country
Ireland
Facility Name
Research Site
City
Galway
Country
Ireland
Facility Name
Research Site
City
Limerick
Country
Ireland
Facility Name
Research site
City
Cosenza
State/Province
Basilicata
Country
Italy
Facility Name
Research Site
City
Benevento
State/Province
Campania
Country
Italy
Facility Name
Research Site
City
Mantova
State/Province
Lombardia
Country
Italy
Facility Name
Research Site
City
Rozzano (Milano)
State/Province
Lombardia
Country
Italy
Facility Name
Research Site
City
Bari
State/Province
Puglia
Country
Italy
Facility Name
Research Site
City
Catania
State/Province
Sicilia
Country
Italy
Facility Name
Research Site
City
Pisa
State/Province
Toscana
Country
Italy
Facility Name
Research Site
City
Perugia
State/Province
Umbria
Country
Italy
Facility Name
Research Site
City
Verona
State/Province
Veneto
Country
Italy
Facility Name
Research Site
City
Bolzano
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Padova
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Aveiro
Country
Portugal
Facility Name
Research Site
City
Braga
Country
Portugal
Facility Name
Research Site
City
Carnaxide
Country
Portugal
Facility Name
Research Site
City
Faro
Country
Portugal
Facility Name
Research Site
City
Funchal
Country
Portugal
Facility Name
Research Site
City
Leiria
Country
Portugal
Facility Name
Research Site
City
Vila Real
Country
Portugal
Facility Name
Research Site
City
Zaragoza
State/Province
Aragón
Country
Spain
Facility Name
Research Site
City
Toledo
State/Province
Castilla la Mancha
Country
Spain
Facility Name
Research Site
City
Tarragona
State/Province
Cataluña
Country
Spain
Facility Name
Research Site
City
San Juan de Alicante
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
Fuenlabrada(Madrid)
State/Province
Madrid
Country
Spain
Facility Name
Research Site
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Research site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Bab Saâdoun Tunis
Country
Tunisia
Facility Name
Research Site
City
Sidi Daoud Tunis
Country
Tunisia
Facility Name
Research Site
City
Sousse
Country
Tunisia
Facility Name
Research Site
City
Tunis
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20417447
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs