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

Phase 3

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT00296387
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-27
• Study Completion: 2007-10
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-12
• Last Update Posted: 2007-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage changes in ApoB/ApoA-I levels	from Day 0 to 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Research site; 🇪🇸 Madrid, Spain

Research Site; 🇹🇳 Tunis, Tunisia