ACT II: 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)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01381679
• Collaborator: (none)
• Enrollment: 1,682
• Duration (Months): 19

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Ezetimibe

Study Design

• Study Type: Observational
• Actual Enrollment: 1682 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Austrian Cholesterol Screening And Treatment II (ACT II)
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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

2. Change From Baseline in TC at Month 12 [Baseline and Month 12]

3. Change From Baseline in LDL-C at Month 3 [Baseline and Month 3]

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

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

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

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

8. Change From Baseline in TG at Month 12 [Baseline and Month 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01381679
• Other Study ID Numbers: 0653A-205
• First Posted: Jun 27, 2011
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Hypercholesterolemia; Ezetimibe

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Period Title: Overall Study
STARTED	1682
COMPLETED	794
NOT COMPLETED	888

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Overall Participants	1682
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.58 (10.4)
Sex/Gender, Customized (Number) [Number]
Males	1003 59.6%
Females	655 38.9%
Not Reported	24 1.4%
Region of Enrollment (participants) [Number]
Austria	1682 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	1682
Number [Participants]	678 40.3%

2. Secondary Outcome

Title	Change From Baseline in Total Cholesterol (TC) at Month 3
Time Frame	Baseline and Month 3

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	782
Mean (95% Confidence Interval) [mg/dL]	-46.6 (40.5)

3. Secondary Outcome

Title	Change From Baseline in TC at Month 12
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	782
Mean (95% Confidence Interval) [mg/dL]	-54.5 (37.62)

4. Secondary Outcome

Title	Change From Baseline in LDL-C at Month 3
Time Frame	Baseline and Month 3

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	750
Mean (95% Confidence Interval) [mg/dL]	-41.7 (31.81)

5. Secondary Outcome

Title	Change From Baseline in LDL-C at Month 12
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	750
Mean (95% Confidence Interval) [mg/dL]	-49.3 (26.64)

6. Secondary Outcome

Title	Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3
Time Frame	Baseline and Month 3

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	774
Mean (95% Confidence Interval) [mg/dL]	2.8 (14.17)

7. Secondary Outcome

Title	Change From Baseline in HDL-C at Month 12
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	774
Mean (95% Confidence Interval) [mg/dL]	4.0 (15.05)

8. Secondary Outcome

Title	Change From Baseline in Triglycerides (TG) at Month 3
Time Frame	Baseline and Month 3

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	756
Mean (95% Confidence Interval) [mg/dL]	-33.8 (82.51)

9. Secondary Outcome

Title	Change From Baseline in TG at Month 12
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.

Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Measure Participants	756
Mean (95% Confidence Interval) [mg/dL]	-43.9 (75.06)

Adverse Events

Time Frame	12 months
Arm/Group Title	All Participants
Arm/Group Description	Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	3/1682 (0.2%)
Hepatobiliary disorders
Cholecystitis	1/1682 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma	1/1682 (0.1%)	1
Bronchial Neoplasm	1/1682 (0.1%)	1
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/1682 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.