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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01190072
• Other study ID #: NIS-CSI-DUM-2010/1
• Status: Terminated
• Phase: N/A
• First received: August 26, 2010
• Last updated: January 28, 2013
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Slovenia	Research Site	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum total cholesterol concentration		Week 0	No
Primary	Serum total cholesterol concentration		Once during the time period between Week 6 and Week 10	No
Primary	Serum LDL cholesterol concentration		Week 0	No
Primary	Serum LDL cholesterol concentration		Once during the time period between Week 6 and Week 10	No
Secondary	Proportion of patients achieving LDL-C < 2 mmol/L		Once during the time period between Week 6 and Week 10	No
Secondary	Proportion of patients achieving total cholesterol < 4 mmol/L		Once during the time period between Week 6 and Week 10	No
Secondary	Change of hsCRP levels from baseline		Once during the time period between Week 6 and Week 10	No