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This study is being performed to evaluate what variants of lipid-lowering therapy are used in Russian clinical practice in coronary heart disease (CHD) patients with hypercholesterolemia in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol (LDL-C) goals. Additionally, the efficacy and safety of all variants of modified lipid-lowering therapy are to be evaluated.
Given the observational nature of this study and that the assessment of a specific hypothesis is not foreseen, statistical assumption is not planned and the sample size calculation was not performed.
Taking into consideration the available data on the established safety profile of the therapy with statins and combination of ezetimibe with statins it has been suggested that a sample size of 750 patients will be sufficient to identify adverse events profile.
The treatment effects will be characterized by descriptive and frequency parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Statin | Group 1 - Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) whose lipid-lowering therapy was modified by transition to a new statin treatment |
| |
| Statin Dose Titration | Group 2 - Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) whose lipid-lowering therapy was modified by increasing the dose of ongoing statin treatment |
| |
| Ezetimibe added to existing statin | Group 3 - Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin. | Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin). | During the study |
| Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation | Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin). | Visit 2 (Month 2, end of observation) |
| Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation | Visit 2 (Month 2, end of observation) | |
| Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups | Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline) | |
| Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups | Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline) |
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Inclusion Criteria:
(TC> 4.5 mmol\L; LDL-C> 2.5 mmol/L);
Exclusion Criteria:
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Patients with established diagnosis of coronary heart disease (CHD) and hypercholesterolemia who did not achieve the target values for total cholesterol (TC) and low density lipoprotein-C (LDL-C) with existing statin therapy
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Patients | Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin. | Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin). | The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol violations were recorded. One subject each from ezetimibe added to existing statin and new statin group were excluded (missing data) | Posted | Number | Percentage of patients | During the study |
|
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Adverse Events (AEs) and Serious Adverse Events (SAEs) are represented for all treatment subjects (n=712) not by treatment group because in this observational study the three treatment group populations cannot be clearly identified for a substantial number of subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Patients | Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac asthma | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Statin | Drug | Statin titration for the Statin Dose Titration group, and new statin treatment and dosage for the New Statin group, determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients |
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C. A participant was included in the study in case the lipid lowering therapy was modified in one of the following options: 1- statin dose (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) titration, 2- administration of a new statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin), 3- administration of ezetimibe in addition to current statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) therapy. |
|
|
| Primary | Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation | Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin). | The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data. | Posted | Number | Percentage of patients | Visit 2 (Month 2, end of observation) |
|
|
|
|
| Primary | Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation | The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. | Posted | Number | Percentage of patients | Visit 2 (Month 2, end of observation) |
|
|
|
|
| Primary | Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups | The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data. | Posted | Mean | Standard Deviation | mmol/L | Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline) |
|
|
|
|
| Primary | Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups | The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data. | Posted | Mean | Standard Deviation | mmol/L | Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline) |
|
|
|
|
| 3 |
| 712 |
| 0 |
| 712 |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastric hemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vascular graft | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
A disclosure agreement restricts the rights on publications within 5 years after the document is signed off. The Clinical Trial Agreement restricts the rights on publication within 5 years after the trial completion.
| D006949 |
| Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000924 |
| Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| Mean Difference (Final Values) |
| 20.00 |
| Standard Deviation |
| 15.662 |
| 95 |
| Superiority or Other (legacy) |
| Descriptive statistics of relative (%) change in TC from baseline at Visit 2 | Mean Difference (Final Values) | 22.8181 | Standard Deviation | 14.03545 | 95 | Superiority or Other (legacy) |
| Statin Dose Titration compared to New Statin | Games-Howell | .143 | Mean Difference (Final Values) | -2.80928 | Standard Error of the Mean | 1.48621 | 2-Sided | 95 | -6.3070 | .6884 | Superiority or Other (legacy) |
| Statin Dose Titration compared to Ezetimbe | Games-Howell | .001 | Mean Difference (Final Values) | -5.74811 | Standard Error of the Mean | 1.56351 | 2-Sided | 95 | -9.4298 | -2.0664 | Superiority or Other (legacy) |
| New Statin compared to Ezetimibe | Games-Howell | .086 | Mean Difference (Final Values) | -2.93883 | Standard Error of the Mean | 1.38286 | 2-Sided | 95 | -6.1948 | .3171 | Superiority or Other (legacy) |
| Mean Difference (Final Values) |
| 28.2488 |
| Standard Deviation |
| 20.78727 |
| 95 |
| Superiority or Other (legacy) |
| Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1) | Mean Difference (Final Values) | 32.0665 | Standard Deviation | 15.59010 | 95 | Superiority or Other (legacy) |
| Statin Dose Titration compared to New Statin | Games-Howell | .756 | Mean Difference (Final Values) | -1.43138 | Standard Error of the Mean | 2.01009 | 2-Sided | 95 | -6.1604 | 3.2977 | Superiority or Other (legacy) |
| Statin Dose Titration compared to Ezetimibe | Games-Howell | .023 | Mean Difference (Final Values) | -5.24911 | Standard Error of the Mean | 1.97821 | 2-Sided | 95 | -9.9072 | -.5910 | Superiority or Other (legacy) |
| New Statin compared to Ezetimibe | Games-Howell | .107 | Mean Difference (Final Values) | -3.81773 | Standard Error of the Mean | 1.88425 | 2-Sided | 95 | -8.2523 | .6169 | Superiority or Other (legacy) |