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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01190072
First received: August 26, 2010
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Serum total cholesterol concentration [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Serum total cholesterol concentration [ Time Frame: Once during the time period between Week 6 and Week 10 ] [ Designated as safety issue: No ]
  • Serum LDL cholesterol concentration [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Serum LDL cholesterol concentration [ Time Frame: Once during the time period between Week 6 and Week 10 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving total cholesterol < 4 mmol/L [ Time Frame: Once during the time period between Week 6 and Week 10 ] [ Designated as safety issue: No ]
  • Change of hsCRP levels from baseline [ Time Frame: Once during the time period between Week 6 and Week 10 ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Secondary care clinic

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190072

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014