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Study design: Observational Model: Cohort, Time Perspective: Prospective
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.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
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
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
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
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: January 2008
Last updated: June 23, 2015