## Protocol Section
### Identification Module
**NCT ID:** NCT01381679

**Acronym:** ACT II

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** 0653A-205
#### Organization
**Class:** INDUSTRY
**Full Name:** Organon and Co
### Status Module
#### Completion Date
**Date:** 2010-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-09

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-03-22

**Type:** ESTIMATED

**Results First Submit Date:** 2011-11-23

**Results First Submit QC Date:** 2012-02-17

#### Start Date
**Date:** 2009-05

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2011-06-27
**Type:** ESTIMATED
**Study First Submit Date:** 2011-06-23
**Study First Submit QC Date:** 2011-06-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Organon and Co

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Hypercholesterolemia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1682

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Ezetimibe

**Label:** All participants

### Interventions

#### Intervention 1

**Arm Group Labels:**

- All participants

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

**Name:** Ezetimibe

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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

**Measure:** Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level

**Time Frame:** Up to 12 months

#### Secondary Outcomes

**Measure:** Change From Baseline in Total Cholesterol (TC) at Month 3

**Time Frame:** Baseline and Month 3

**Measure:** Change From Baseline in TC at Month 12

**Time Frame:** Baseline and Month 12

**Measure:** Change From Baseline in LDL-C at Month 3

**Time Frame:** Baseline and Month 3

**Measure:** Change From Baseline in LDL-C at Month 12

**Time Frame:** Baseline and Month 12

**Measure:** Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3

**Time Frame:** Baseline and Month 3

**Measure:** Change From Baseline in HDL-C at Month 12

**Time Frame:** Baseline and Month 12

**Measure:** Change From Baseline in Triglycerides (TG) at Month 3

**Time Frame:** Baseline and Month 3

**Measure:** Change From Baseline in TG at Month 12

**Time Frame:** Baseline and Month 12

### Eligibility Module

**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.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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)

### References Module

#### 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.

**PMID:** 23979353

**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.

**PMID:** 22856551

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006949

- Term: Hyperlipidemias

- ID: D000050171

- Term: Dyslipidemias

- ID: D000052439

- Term: Lipid Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9988

- Name: Hypercholesterolemia

- Relevance: HIGH

- As Found: Hypercholesterolemia

- ID: M10000

- Name: Hyperlipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M10002

- Name: Hyperlipoproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M26181

- Name: Dyslipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27029

- Name: Lipid Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006937

- Term: Hypercholesterolemia

### Intervention Browse Module - Ancestors

- ID: D000000924

- Term: Anticholesteremic Agents

- ID: D000000960

- Term: Hypolipidemic Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000057847

- Term: Lipid Regulating Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M409

- Name: Ezetimibe

- Relevance: HIGH

- As Found: Amount

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4243

- Name: Anticholesteremic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4278

- Name: Hypolipidemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M28883

- Name: Lipid Regulating Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069438

- Term: Ezetimibe

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** All Participants

**Description:** Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.

**ID:** EG000

**Other Num at Risk:** 1682

**Serious Number Affected:** 3

**Serious Number At Risk:** 1682

**Title:** All Participants

**Frequency Threshold:** 5

#### Serious Events

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 1682

**Num Events:** 1

**Term:** Basal Cell Carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 1682

**Num Events:** 1

**Term:** Bronchial Neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 1682

**Num Events:** 1

**Time Frame:** 12 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 1682

**Units:** Participants

### Group

**ID:** BG000

**Title:** All Participants

**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

#### Measurement

**Group ID:** BG000

**Spread:** 10.4

**Value:** 64.58

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1003

**Class Title:** Males

#### Measurement

**Group ID:** BG000

**Value:** 655

**Class Title:** Females

#### Measurement

**Group ID:** BG000

**Value:** 24

**Class Title:** Not Reported

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1682

**Class Title:** Austria

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Sex/Gender, Customized
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialsDisclosure@merck.com
**Organization:** Merck Sharp & Dohme Corp
**Phone:** 1-800-672-6372
**Title:** Senior Vice President, Global Clinical Development
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 678
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -49.4
- **Spread:** 40.5
- **Upper Limit:** -43.8
- **Value:** -46.6
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -57.7
- **Spread:** 37.62
- **Upper Limit:** -51.3
- **Value:** -54.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -44.2
- **Spread:** 31.81
- **Upper Limit:** -39.3
- **Value:** -41.7
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -51.9
- **Spread:** 26.64
- **Upper Limit:** -46.7
- **Value:** -49.3
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.0
- **Spread:** 14.17
- **Upper Limit:** 3.6
- **Value:** 2.8
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.1
- **Spread:** 15.05
- **Upper Limit:** 5.0
- **Value:** 4.0
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -41.1
- **Spread:** 82.51
- **Upper Limit:** -26.6
- **Value:** -33.8
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -51.5
- **Spread:** 75.06
- **Upper Limit:** -36.4
- **Value:** -43.9
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Up to 12 months
**Title:** Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level
**Type:** PRIMARY
**Unit of Measure:** Participants
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 2
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 3
**Title:** Change From Baseline in Total Cholesterol (TC) at Month 3
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 3
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 12
**Title:** Change From Baseline in TC at Month 12
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 4
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 3
**Title:** Change From Baseline in LDL-C at Month 3
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 5
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 12
**Title:** Change From Baseline in LDL-C at Month 12
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 6
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 3
**Title:** Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 7
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 12
**Title:** Change From Baseline in HDL-C at Month 12
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 8
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 3
**Title:** Change From Baseline in Triglycerides (TG) at Month 3
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 9
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Month 12
**Title:** Change From Baseline in TG at Month 12
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### 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.
**ID:** OG000
**Title:** All Participants
### Participant Flow Module
#### 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.
**ID:** FG000
**Title:** All Participants
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 885
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1682
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 794
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 888
**Has Results:** True