Lipid-lowering Therapy for Secondary Prevention in Patients Undergoing Elective Percutaneous Coronary Intervention (PCI)

Terminated

• Conditions: Coronary Artery Disease

• Registration Number: NCT01190072
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to follow the management of blood lipids in patients with planned percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10 weeks after the intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Study Start: 2010-09
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Male or nonpregnant female
• Coronary patient hospitalised for elective PCI
• Hypercholesterolaemia defined as LDL-C ≥ 2 mmol/L

Exclusion Criteria

• Any chronic inflammatory condition
• Chronic anti-inflammatory pharmacotherapy (except low-dose ASA)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum total cholesterol concentration	Once during the time period between Week 6 and Week 10
Serum LDL cholesterol concentration	Once during the time period between Week 6 and Week 10

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving LDL-C < 2 mmol/L	Once during the time period between Week 6 and Week 10
Proportion of patients achieving total cholesterol < 4 mmol/L	Once during the time period between Week 6 and Week 10
Change of hsCRP levels from baseline	Once during the time period between Week 6 and Week 10

Trial Locations

Locations (1)

Research Site; 🇸🇮 Maribor, Slovenia