LIPID-LOWERING THERAPY FOR SECONDARY PREVENTION IN PATIENTS UNDERGOING ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) A 10-week, Open-label, Non-interventional Study of Total Cholesterol/LDL-cholesterol Management in Real Life in Coronary Patients Hospitalised for Elective PCI

AstraZeneca1 site in 1 country120 target enrollmentSeptember 2010

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: AstraZeneca
Enrollment: 120
Locations: 1
Primary Endpoint: Serum total cholesterol concentration
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

March 2011

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Serum total cholesterol concentration

Time Frame: Once during the time period between Week 6 and Week 10

Serum LDL cholesterol concentration

Time Frame: Once during the time period between Week 6 and Week 10

Secondary Outcomes

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)