Trial Outcomes & Findings for Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464) (NCT NCT00730132)
NCT ID: NCT00730132
Last Updated: 2022-02-09
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
712 participants
Primary outcome timeframe
During the study
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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712
|
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Overall Study
COMPLETED
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557
|
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Overall Study
NOT COMPLETED
|
155
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Protocol Violation
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154
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Overall Study
Death
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1
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Baseline Characteristics
Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)
Baseline characteristics by cohort
| Measure |
Enrolled Patients
n=712 Participants
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.
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|---|---|
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Age, Continuous
|
59.57 years
STANDARD_DEVIATION 9.367 • n=99 Participants
|
|
Sex/Gender, Customized
Female
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324 participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
386 participants
n=99 Participants
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Sex/Gender, Customized
Not Reported
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2 participants
n=99 Participants
|
|
Region of Enrollment
Russian Federation
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712 participants
n=99 Participants
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PRIMARY outcome
Timeframe: During the studyPopulation: 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)
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).
Outcome measures
| Measure |
All Participants Analyzed
n=557 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.
|
Statin Dose Titration
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 increasing the dose of ongoing statin therapy
|
New Statin
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 transition to a new statin therapy
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|---|---|---|---|
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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.
Statin dose titration
|
32.1 Percentage of patients
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—
|
—
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|
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.
New statin administered
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42.4 Percentage of patients
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—
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—
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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.
Ezetimibe added on to existing statin
|
25.5 Percentage of patients
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—
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—
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PRIMARY outcome
Timeframe: Visit 2 (Month 2, end of observation)Population: 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.
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).
Outcome measures
| Measure |
All Participants Analyzed
n=141 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.
|
Statin Dose Titration
n=179 Participants
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 increasing the dose of ongoing statin therapy
|
New Statin
n=235 Participants
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 transition to a new statin therapy
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|---|---|---|---|
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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
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50.4 Percentage of patients
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33.5 Percentage of patients
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37.4 Percentage of patients
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PRIMARY outcome
Timeframe: Visit 2 (Month 2, end of observation)Population: 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.
Outcome measures
| Measure |
All Participants Analyzed
n=142 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.
|
Statin Dose Titration
n=179 Participants
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 increasing the dose of ongoing statin therapy
|
New Statin
n=235 Participants
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 transition to a new statin therapy
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|---|---|---|---|
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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
|
42.3 Percentage of patients
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26.3 Percentage of patients
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33.9 Percentage of patients
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PRIMARY outcome
Timeframe: Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)Population: 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.
Outcome measures
| Measure |
All Participants Analyzed
n=141 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.
|
Statin Dose Titration
n=179 Participants
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 increasing the dose of ongoing statin therapy
|
New Statin
n=235 Participants
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 transition to a new statin therapy
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|---|---|---|---|
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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
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25.76 mmol/L
Standard Deviation 12.306
|
20.01 mmol/L
Standard Deviation 15.662
|
22.82 mmol/L
Standard Deviation 14.035
|
PRIMARY outcome
Timeframe: Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)Population: 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.
Outcome measures
| Measure |
All Participants Analyzed
n=142 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.
|
Statin Dose Titration
n=179 Participants
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 increasing the dose of ongoing statin therapy
|
New Statin
n=235 Participants
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 transition to a new statin therapy
|
|---|---|---|---|
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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
|
32.06 mmol/L
Standard Deviation 15.590
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26.81 mmol/L
Standard Deviation 19.852
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28.24 mmol/L
Standard Deviation 20.787
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Adverse Events
Enrolled Patients
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enrolled Patients
n=712 participants at risk
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.
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|---|---|
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Cardiac disorders
Cardiac asthma
|
0.14%
1/712 • Number of events 1
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.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.14%
1/712 • Number of events 1
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.
|
|
Cardiac disorders
Coronary artery disease
|
0.14%
1/712 • Number of events 1
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.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.14%
1/712 • Number of events 1
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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|
Nervous system disorders
Hypotonia
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0.14%
1/712 • Number of events 1
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.
|
|
Surgical and medical procedures
Vascular graft
|
0.14%
1/712 • Number of events 1
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER