Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)

An observational study of Coronary Heart Disease and Hypercholesterolemia, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Heart Disease, Hypercholesterolemia
What is being tested?: Ezetimibe and Statin
How many people: 712 participants
Where: No sites listed yet
Study dates: Jan 2008to Aug 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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

Who may be able to join

Male and Female, from 18 to 75 years old;
Established diagnosis of CHD;
Previous (at least, within 1 month before inclusion in the present study) treatment with statin;
Levels of plasma TC and LDL-C above the recommended target values
(TC> 4.5 mmol\L; LDL-C> 2.5 mmol/L);
The written informed consent signed prior to the start of participation in the study.

Who cannot join

Contraindications for statin and ezetimibe (Ezetrol) administration in accordance with local Russian Federation medical instructions.
Patients refused to participate in the study and/or did not sign informed consent form.

About this study

Official title: Observational Study of Approaches to Lipid-lowering Therapy in Russian Patients With Coronary Heart Disease (<<Treat to Goal>>)

Read the detailed description

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.

Conditions: Coronary Heart Disease, Hypercholesterolemia
Being tested: Ezetimibe, Statin
Medical subject headings: Coronary Disease, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EzetimibeDrug
Also called SCH 58235, Ezetrol
Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients
StatinDrug
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

Study groups in NCT00730132
Study group	Role	What they receive
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 Receives: Drug: Statin
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 Receives: Drug: Statin
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 Receives: Drug: Ezetimibe

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Aug 2009

First posted8 Aug 2008 (estimated)
Study startJan 2008
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 712 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730132
Sponsor's protocol ID: P05464
Status last verified: Feb 2022
First submitted: 25 Jul 2008
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of Approaches to Lipid-lowering Therapy in Russian Patients With Coronary Heart Disease (<<Treat to Goal>>)
ClinicalTrials.gov ID: NCT00730132
Acronym / sponsor ID: P05464
Conditions: Coronary Heart Disease, Hypercholesterolemia
Study type: Observational
Recruitment status: Completed
Enrolment: 712 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 11 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

The treatment effects will be characterized by descriptive and frequency parameters.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
New Statin	–	Drug: StatinGroup 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	–	Drug: StatinGroup 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	–	Drug: EzetimibeGroup 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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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

Key inclusion criteria (6 listed)

Male and Female, from 18 to 75 years old;
Established diagnosis of CHD;
Previous (at least, within 1 month before inclusion in the present study) treatment with statin;
Levels of plasma TC and LDL-C above the recommended target values
(TC> 4.5 mmol\L; LDL-C> 2.5 mmol/L);

Key exclusion criteria (2 listed)

Contraindications for statin and ezetimibe (Ezetrol) administration in accordance with local Russian Federation medical instructions.
Patients refused to participate in the study and/or did not sign informed consent form.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EzetimibeAlso: SCH 58235, EzetrolDosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients	Drug	Ezetimibe added to existing statin
StatinStatin 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	Drug	New Statin, Statin Dose Titration

Primary outcome

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.
Time frame: During the study
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).
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
Time frame: Visit 2 (Month 2, 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).
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
Time frame: 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
Time frame: 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
Time frame: Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)

Results and safety

Results posted to the registry on 11 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enrolled Patients	712	557

Primary outcome: 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.

Time frame: During the study. Number. Unit: Percentage of patients

Measure	All Participants Analyzed n = 557
Statin dose titration	32.1
New statin administered	42.4
Ezetimibe added on to existing statin	25.5

Population analysed: 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)

Primary outcome: 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

Time frame: Visit 2 (Month 2, end of observation). Number. Unit: Percentage of patients

Measure	Ezetimibe Added to Existing Statin n = 141	Statin Dose Titration n = 179	New Statin n = 235
Value	50.4	33.5	37.4

Ezetimibe Added to Existing Statin vs Statin Dose Titration vs New Statin: p = 0.007, Pearson Chi-Square

Population analysed: 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.

Primary outcome: 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

Time frame: Visit 2 (Month 2, end of observation). Number. Unit: Percentage of patients

Measure	Ezetimibe Added to Existing Statin n = 142	Statin Dose Titration n = 179	New Statin n = 235
Value	42.3	26.3	33.9

Ezetimibe Added to Existing Statin vs Statin Dose Titration vs New Statin: p <0.001, McNemar

Primary outcome: 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

Time frame: Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline). Mean (Standard Deviation). Unit: mmol/L

Measure	Ezetimibe Added to Existing Statin n = 141	Statin Dose Titration n = 179	New Statin n = 235
Value	25.76 (12.306)	20.01 (15.662)	22.82 (14.035)

Ezetimibe Added to Existing Statin: Mean Difference (Final Values): 25.7570
Statin Dose Titration: Mean Difference (Final Values): 20.00
New Statin: Mean Difference (Final Values): 22.8181

Population analysed: 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.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enrolled Patients	3 of 712 (0.4%)	0 of 712 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease and Hypercholesterolemia, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: During the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00730132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.