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)

Study Overview
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Brief Summary
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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.

Official Title
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Austrian Cholesterol Screening And Treatment II (ACT II)

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Ezetimibe


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen. | Drug: Ezetimibe<br>* Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | 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 | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Cholesterol (TC) at Month 3 |  | Baseline and Month 3 | 
| Change From Baseline in TC at Month 12 |  | Baseline and Month 12 | 
| Change From Baseline in LDL-C at Month 3 |  | Baseline and Month 3 | 
| Change From Baseline in LDL-C at Month 12 |  | Baseline and Month 12 | 
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 |  | Baseline and Month 3 | 
| Change From Baseline in HDL-C at Month 12 |  | Baseline and Month 12 | 
| Change From Baseline in Triglycerides (TG) at Month 3 |  | Baseline and Month 3 | 
| Change From Baseline in TG at Month 12 |  | Baseline and Month 12 |