Clinical trial NCT00730132: Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)
Official title: Observational Study of Approaches to Lipid-lowering Therapy in Russian Patients With Coronary Heart Disease (<<Treat to Goal>>)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
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.
timeFrame: During the study
measure: 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
timeFrame: Visit 2 (Month 2, end of observation)
measure: 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
timeFrame: Visit 2 (Month 2, end of observation)
measure: 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
timeFrame: Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)
measure: 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
timeFrame: Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: