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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ezetimibe

Drug

Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients

Other names: SCH 58235, Ezetrol

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

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Aug 8, 2008
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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