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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296387
• Other study ID #: D3560L00052
• Secondary ID: CENTAURUS
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: December 12, 2007
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesIreland: Irish Medicines BoardPortugal: National Pharmacy and Medicines InstituteBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1160
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Rosuvastatin

• Atorvastatin

Locations

Country	Name	City	State
Belgium	Research Site	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
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Pointe-claire	Quebec
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Saint John	New Brunswick
Canada	Research Site	Saint-charles-borromee	Quebec
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Winnipeg	Manitoba
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
France	Research Site	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	La Roche Sur Yon
France	Research Site	LAGNY sur MARNE
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	Paris
France	Research Site	PAU
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
Greece	Research Site	Athens
Hungary	Research Site	Balatonfüred
Hungary	Research Site	Budapest
Hungary	Research Site	Pecs
Hungary	Research Site	Zalaegerszeg
Ireland	Research Site	Dublin
Ireland	Research Site	Galway
Ireland	Research Site	Limerick
Italy	Research Site	Bari	Puglia
Italy	Research Site	Benevento	Campania
Italy	Research Site	Bolzano
Italy	Research Site	Catania	Sicilia
Italy	Research site	Cosenza	Basilicata
Italy	Research Site	Mantova	Lombardia
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Perugia	Umbria
Italy	Research Site	Pisa	Toscana
Italy	Research Site	Roma
Italy	Research Site	Rozzano (Milano)	Lombardia
Italy	Research Site	Verona	Veneto
Portugal	Research Site	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
Spain	Research Site	Fuenlabrada(Madrid)	Madrid
Spain	Research site	Madrid
Spain	Research Site	San Juan de Alicante	Comunidad Valenciana
Spain	Research Site	Sevilla
Spain	Research Site	Tarragona	Cataluña
Spain	Research Site	Toledo	Castilla la Mancha
Spain	Research Site	Vigo	Pontevedra
Spain	Research Site	Zaragoza	Aragón
Tunisia	Research Site	Bab Saâdoun Tunis
Tunisia	Research Site	Sidi Daoud Tunis
Tunisia	Research Site	Sousse
Tunisia	Research Site	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Canada,  Estonia,  France,  Greece,  Hungary,  Ireland,  Italy,  Portugal,  Spain,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage changes in ApoB/ApoA-I levels		from Day 0 to 3 months
Secondary	Percentage changes in LDL-C		from Day 0 to 1 month and 3 months
Secondary	Percentage changes in the hs-CRP and AUC of hs-CRP levels		from Day -6 to Day 0
Secondary	Percentage changes in ApoA-I		from Day 0 to 1 month