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Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1) (ACT II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01381679
First received: June 23, 2011
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  Purpose

This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.


Condition Intervention
Hypercholesterolemia
 Drug: Ezetimibe

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Austrian Cholesterol Screening And Treatment II (ACT II)

Resource links provided by NLM:

Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively


Secondary Outcome Measures:
  • Change From Baseline in Total Cholesterol (TC) at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in TC at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in LDL-C at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in LDL-C at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in HDL-C at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Triglycerides (TG) at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in TG at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

Enrollment: 1682
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen.
 Drug: Ezetimibe
Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants without adequate LDL-cholesterol reduction with a statin, representative cross-section across all regions/parts of Austria (federal provinces, urban/rural areas, office-based internists/general practitioners)

Criteria

Inclusion criteria:

  • Participants in whom LDL-cholesterol target levels have not been achieved.
  • Participants in whom a decision has been made by the physician to initiate treatment with ezetimibe (longitudinal analyses). The treatment decision will be made prior to and independent from inclusion of participants into this study.
  • Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.

Exclusion criteria:

  • Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe.
  • In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial.
  • Previous and ongoing treatment with ezetimibe.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01381679     History of Changes
Other Study ID Numbers: MK-0653A-205
Study First Received: June 23, 2011
Results First Received: November 23, 2011
Last Updated: February 17, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Coronary Disease
Hypercholesterolemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013