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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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013