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Completed

NCT Number: NCT01381679

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)

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ezetimibe

Drug

Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.

Primary outcomes

  1. Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level

    Time frame: Up to 12 months

    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 outcomes

  1. Change From Baseline in Total Cholesterol (TC) at Month 3

    Time frame: Baseline and Month 3

  2. Change From Baseline in TC at Month 12

    Time frame: Baseline and Month 12

  3. Change From Baseline in LDL-C at Month 3

    Time frame: Baseline and Month 3

  4. Change From Baseline in LDL-C at Month 12

    Time frame: Baseline and Month 12

  5. Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3

    Time frame: Baseline and Month 3

  6. Change From Baseline in HDL-C at Month 12

    Time frame: Baseline and Month 12

  7. Change From Baseline in Triglycerides (TG) at Month 3

    Time frame: Baseline and Month 3

  8. Change From Baseline in TG at Month 12

    Time frame: Baseline and Month 12

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Austrian Cholesterol Screening And Treatment II (ACT II)

Acronym: ACT II

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 27, 2011
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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