Clinical trial 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)
Official title: Austrian Cholesterol Screening And Treatment II (ACT II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 1682
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change From Baseline in Total Cholesterol (TC) at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in TC at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in LDL-C at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in LDL-C at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in HDL-C at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in Triglycerides (TG) at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in TG at Month 12
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
Study officials:
References:
citation: Pichler M, Lautsch D, Adler C, Bogl K, Drexel H, Eber B, Fauer C, Fochterle J, Foger B, Gansch K, Grafinger P, Lechleitner M, Ludvik B, Maurer G, Morz R, Paulweber B, Pfeiffer KP, Prager R, Stark G, Toplak H, Traindl O, Weitgasser R. Are there differences in LDL-C target value attainment in Austrian federal states? Yes! Wien Med Wochenschr. 2013 Dec;163(23-24):528-35. doi: 10.1007/s10354-013-0219-z. Epub 2013 Aug 27.
citation: Eber B, Lautsch D, Fauer C, Drexel H, Pfeiffer KP, Traindl O, Pichler M. Can LDL-cholesterol targets be achieved in a population at high risk? Results of the non-interventional study ACT II. Curr Med Res Opin. 2012 Sep;28(9):1447-54. doi: 10.1185/03007995.2012.717919. Epub 2012 Aug 16.