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

NCT ID: NCT00730132

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 712 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-08-31

Brief 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. Additionally, the efficacy and safety of all variants of modified lipid-lowering therapy are to be evaluated.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: 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

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

Statin

Intervention Type: 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

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

Ezetimibe

Intervention Type: DRUG

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

Interventions

Ezetimibe

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

SCH 58235; Ezetrol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05464

Identifier Type: -

Identifier Source: org_study_id