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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Coronary Heart Disease
• Intervention / Treatment: Drug: Statin; Drug: Ezetimibe

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.

• Study Type: Observational
• Enrollment (Actual): 712

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Statin; 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
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	Drug: Statin; 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
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	Drug: Ezetimibe; Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients; Other Names: SCH 58235; Ezetrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: August 5, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe
• Other Study ID Numbers: P05464