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

This study has been terminated.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: August 26, 2010
Last updated: January 28, 2013
Last verified: January 2013
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.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Serum total cholesterol concentration [ Time Frame: Week 0 ]
  • Serum total cholesterol concentration [ Time Frame: Once during the time period between Week 6 and Week 10 ]
  • Serum LDL cholesterol concentration [ Time Frame: Week 0 ]
  • Serum LDL cholesterol concentration [ Time Frame: Once during the time period between Week 6 and Week 10 ]

Secondary Outcome Measures:
  • Proportion of patients achieving LDL-C < 2 mmol/L [ Time Frame: Once during the time period between Week 6 and Week 10 ]
  • Proportion of patients achieving total cholesterol < 4 mmol/L [ Time Frame: Once during the time period between Week 6 and Week 10 ]
  • Change of hsCRP levels from baseline [ Time Frame: Once during the time period between Week 6 and Week 10 ]

Enrollment: 120
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Secondary care clinic

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01190072

Research Site
Maribor, Slovenia
Sponsors and Collaborators
Principal Investigator: Vojko Kanic University Clinical Centre, Maribor
  More Information

Responsible Party: AstraZeneca Identifier: NCT01190072     History of Changes
Other Study ID Numbers: NIS-CSI-DUM-2010/1
Study First Received: August 26, 2010
Last Updated: January 28, 2013

Keywords provided by AstraZeneca:
Blood lipids
percutaneous coronary intervention
lipid lowering treatment

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on May 23, 2017