Clinical trial NCT01483950: Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values
Official title: Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolaemia
Keywords: Dyslipidemia
Statins
Total Cholesterol
Low density lipoprotein (LDL) cholesterol
High density lipoprotein (HDL) cholesterol
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by specialist

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

Eligibility criteria: 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

Primary outcomes:
measure: The number and percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.
timeFrame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Secondary outcomes:
measure: The number and percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
timeFrame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
measure: The number and percentage of patients with high cardiovascular risk reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.
timeFrame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
measure: The number and percentage of patients with high cardiovascular risk reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
timeFrame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Research Site
city: Bijeljina
country: Bosnia and Herzegovina
facility: Research Site
city: Doboj
country: Bosnia and Herzegovina
facility: Research Site
city: Gradiška
country: Bosnia and Herzegovina
facility: Reserach Site
city: Kakanj
country: Bosnia and Herzegovina
facility: Research Site
city: Maglaj
country: Bosnia and Herzegovina
facility: Research Site
city: Prijedor
country: Bosnia and Herzegovina
facility: Research Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Research Site
city: Tešanj
country: Bosnia and Herzegovina
facility: Research Site
city: Trebinje
country: Bosnia and Herzegovina
facility: Research Site
city: Visoko
country: Bosnia and Herzegovina
facility: Research Site
city: Zavidovići
country: Bosnia and Herzegovina
facility: Research Site
city: Zenica
country: Bosnia and Herzegovina
facility: Research Site
city: Zvornik
country: Bosnia and Herzegovina
facility: Research Site
Study officials:
affiliation: Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and Herzegovina
name: Vesna Loza, DOC. DR. SCI. MED
role: PRINCIPAL_INVESTIGATOR
affiliation: West Balkan MD
name: Meta Jeras, MR PH
role: STUDY_DIRECTOR
References: