N/A
Completed N=712
Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)
Source: ClinicalTrials.gov NCT00730132 ↗Enrolled (actual)
712
Serious AEs
0.4%
Results posted
Oct 2010
Primary outcomePrimary: 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. — 32.1; 42.4; 25.5 Percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
32.1; 42.4; 25.5 | — |
| PRIMARY 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 |
50.4; 33.5; 37.4 | 0.007 sig |
| PRIMARY 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 |
42.3; 26.3; 33.9 | <0.001 sig |
| PRIMARY 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 |
25.76; 20.01; 22.82 | .143 |
| PRIMARY 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 |
32.06; 26.81; 28.24 | .756 |
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.
Data sourced from ClinicalTrials.gov (NCT00730132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.