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

August 26, 2010
January 28, 2013
September 2010
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01190072 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Proportion of patients achieving LDL-C < 2 mmol/L [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving LDL-C < 2 mmol/L [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving LDL-C < 2 mmol/L [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving LDL-C < 2 mmol/L [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving LDL-C < 2 mmol/L [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving total cholesterol < 4 mmol/L [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving total cholesterol < 4 mmol/L [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving total cholesterol < 4 mmol/L [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving total cholesterol < 4 mmol/L [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving total cholesterol < 4 mmol/L [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Change of hsCRP levels from baseline [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Change of hsCRP levels from baseline [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
  • Change of hsCRP levels from baseline [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change of hsCRP levels from baseline [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Change of hsCRP levels from baseline [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lipid-lowering Therapy for Secondary Prevention in Patients Undergoing Elective Percutaneous Coronary Intervention (PCI)
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Secondary care clinic

Coronary Artery Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
March 2011
March 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT01190072
NIS-CSI-DUM-2010/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Vojko Kanic University Clinical Centre, Maribor
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP