Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01483950

Enrollment

800

Registered

2011-12-02

Start date

2012-04-30

Completion date

2013-01-31

Last updated

2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

Keywords

Dyslipidemia, Statins, Total Cholesterol, Low density lipoprotein (LDL) cholesterol, High density lipoprotein (HDL) cholesterol

Brief summary

This study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. The investigators will complete Case Report Form (CRF) with patient's demographic, the presence of the factors for high cardiovascular risk, current treatment, cholesterol value as well as with further treatment decision.

Detailed description

Non-interventional study to assess reaching of cholesterol target values in patients treated with HMG-CoA reductase inhibitors in Bosnia and Herzegovina

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients, treated with one HMG-CoA reductase inhibitors for at least 6 months without changing the dose for the last 4 weeks at least * All patients must sign informed consent form

Exclusion criteria

* Patients who have not signed the Informed Consent Form * Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Bosnia and Herzegovina

Design outcomes

Primary

Measure	Time frame
The number and percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Secondary

Measure	Time frame
The number and percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
The number and percentage of patients with high cardiovascular risk reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
The number and percentage of patients with high cardiovascular risk reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Countries

Bosnia and Herzegovina

Outcome results