NCT00296387

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.

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
1,160

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
10 countries

100 active sites

Status
completed

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

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

February 23, 2006

Last Update Submit

December 12, 2007

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage changes in ApoB/ApoA-I levels

    from Day 0 to 3 months

Secondary Outcomes (3)

  • Percentage changes in LDL-C

    from Day 0 to 1 month and 3 months

  • Percentage changes in the hs-CRP and AUC of hs-CRP levels

    from Day -6 to Day 0

  • Percentage changes in ApoA-I

    from Day 0 to 1 month

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (102)

Research Site

Aalst, Belgium

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Bonheiden, Belgium

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Bouge, Belgium

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Brussels, Belgium

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Charleroi, Belgium

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Hasselt, Belgium

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Huy, Belgium

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La Louvière, Belgium

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Leuven, Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Regina, Saskatchewan, Canada

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Tallinn, Estonia

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Tartu, Estonia

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Amiens, France

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Annecy, France

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Arras, France

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Avignon, France

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Boulogne-Billancourt, France

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Caen, France

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Cholet, France

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Créteil, France

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Dijon, France

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Eaubonne, France

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Évecquemont, France

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Falaise, France

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La Roche-sur-Yon, France

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Lagny-sur-Marne, France

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Le Coudray, France

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Le Mans, France

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Lille, France

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Marseille, France

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Metz, France

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Montpellier, France

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Nevers, France

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Paris, France

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Pau, France

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Pessac, France

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Reims, France

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Rouen, France

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Saint-Herblain, France

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Suresnes, France

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Toulouse, France

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Tourcoing, France

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Tours, France

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Valenciennes, France

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Vannes, France

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Villeurbanne, France

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Athens, Greece

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Balatonfüred, Hungary

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Budapest, Hungary

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Pécs, Hungary

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Zalaegerszeg, Hungary

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Dublin, Ireland

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Galway, Ireland

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Limerick, Ireland

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Bari, Apulia, Italy

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Cosenza, Basilicate, Italy

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Benevento, Campania, Italy

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Mantova, Lombardy, Italy

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Rozzano (Milano), Lombardy, Italy

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Catania, Sicily, Italy

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Pisa, Tuscany, Italy

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Perugia, Umbria, Italy

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Verona, Veneto, Italy

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Bolzano, Italy

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Napoli, Italy

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Padua, Italy

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Roma, Italy

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Aveiro, Portugal

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Braga, Portugal

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Carnaxide, Portugal

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Faro, Portugal

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Funchal, Portugal

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Leiria, Portugal

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Vila Real, Portugal

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Zaragoza, Aragon, Spain

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Toledo, Castille-La Mancha, Spain

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Tarragona, Catalonia, Spain

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Fuenlabrada(Madrid), Madrid, Spain

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Madrid, Madrid, Spain

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Vigo, Pontevedra, Spain

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Sant Joan d'Alacant, Valencia, Spain

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Seville, Spain

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BAB Saâdoun Tunis, Tunisia

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SIDI Daoud Tunis, Tunisia

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Sousse, Tunisia

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Tunis, Tunisia

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Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • AstraZeneca France Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 27, 2006

Study Start

January 1, 2006

Study Completion

October 1, 2007

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations