Clinical trial NCT00296387: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-27
Enrollment: 1160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage changes in ApoB/ApoA-I levels
timeFrame: from Day 0 to 3 months
Secondary outcomes:
measure: Percentage changes in LDL-C
timeFrame: from Day 0 to 1 month and 3 months
measure: Percentage changes in the hs-CRP and AUC of hs-CRP levels
timeFrame: from Day -6 to Day 0
measure: Percentage changes in ApoA-I
timeFrame: from Day 0 to 1 month
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Bouge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Huy
country: Belgium
facility: Research Site
city: La Louviere
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Saint John
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Pointe-claire
country: Canada
facility: Research Site
state: Quebec
city: Saint-charles-borromee
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Regina
country: Canada
facility: Research Site
state: Saskatchewan
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Annecy
country: France
facility: Research Site
city: Arras
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Cholet
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Eaubonne
country: France
facility: Research Site
city: Evecquemont
country: France
facility: Research Site
city: Falaise
country: France
facility: Research Site
city: La Roche Sur Yon
country: France
facility: Research Site
city: LAGNY sur MARNE
country: France
facility: Research Site
city: Le Coudray
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nevers
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: PAU
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saint-Herblain
country: France
facility: Research Site
city: Suresnes
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tourcoing
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Valenciennes
country: France
facility: Research Site
city: Vannes
country: France
facility: Research Site
city: Villeurbanne
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Balatonfüred
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Galway
country: Ireland
facility: Research Site
city: Limerick
country: Ireland
facility: Research Site
city: Cosenza
country: Italy
facility: Research site
state: Basilicata
city: Benevento
country: Italy
facility: Research Site
state: Campania
city: Mantova
country: Italy
facility: Research Site
state: Lombardia
city: Rozzano (Milano)
country: Italy
facility: Research Site
state: Lombardia
city: Bari
country: Italy
facility: Research Site
state: Puglia
city: Catania
country: Italy
facility: Research Site
state: Sicilia
city: Pisa
country: Italy
facility: Research Site
state: Toscana
city: Perugia
country: Italy
facility: Research Site
state: Umbria
city: Verona
country: Italy
facility: Research Site
state: Veneto
city: Bolzano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Aveiro
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Carnaxide
country: Portugal
facility: Research Site
city: Faro
country: Portugal
facility: Research Site
city: Funchal
country: Portugal
facility: Research Site
city: Leiria
country: Portugal
facility: Research Site
city: Vila Real
country: Portugal
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
state: Aragón
city: Toledo
country: Spain
facility: Research Site
state: Castilla la Mancha
city: Tarragona
country: Spain
facility: Research Site
state: Cataluña
city: San Juan de Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Fuenlabrada(Madrid)
country: Spain
facility: Research Site
state: Madrid
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Madrid
country: Spain
facility: Research site
city: Sevilla
country: Spain
facility: Research Site
city: Bab Saâdoun Tunis
country: Tunisia
facility: Research Site
city: Sidi Daoud Tunis
country: Tunisia
facility: Research Site
city: Sousse
country: Tunisia
facility: Research Site
city: Tunis
country: Tunisia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director, MD
role: STUDY_DIRECTOR
References:
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.