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)

NCT ID: NCT01381679

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1682 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-12-31

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.

Conditions

Hypercholesterolemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All participants

Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen.

Ezetimibe

Intervention Type: DRUG

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

Interventions

Ezetimibe

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

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 23979353 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22856551 (View on PubMed)

Other Identifiers

0653A-205

Identifier Type: -

Identifier Source: org_study_id