Clinical trial NCT01257971: Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors
Official title: Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolaemia
Keywords: Cholesterol
HMG-CoA reductase inhibitor
cardiovascular risk
LDLl
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-10
Enrollment: 1868
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 is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.


Eligibility criteria: Inclusion Criteria:

* patients who have been treated with one HMG-CoA reductase inhibitor 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 Croatia.

Primary outcomes:
measure: Number 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
measure: 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: Number 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: Number 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: Number 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
measure: 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: 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: 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: Biograd na moru
country: Croatia
facility: Research Site
city: Bjelovar
country: Croatia
facility: Research Site
city: Cakovec
country: Croatia
facility: Research Site
city: Crikvenica
country: Croatia
facility: Research Site
city: Dubrovnik
country: Croatia
facility: Research Site
city: Gospic
country: Croatia
facility: Research Site
city: Karlovac
country: Croatia
facility: Research Site
city: Koprivnica
country: Croatia
facility: Research Site
city: Krapina
country: Croatia
facility: Research Site
city: Krapinske toplice
country: Croatia
facility: Research Site
city: Opatija
country: Croatia
facility: Research Site
city: Osijek
country: Croatia
facility: Research Site
city: Porec
country: Croatia
facility: Research Site
city: Pula
country: Croatia
facility: Research Site
city: Rijeka
country: Croatia
facility: Research Site
city: Sisak
country: Croatia
facility: Research Site
city: Slavonski brod
country: Croatia
facility: Research Site
city: Split
country: Croatia
facility: Research Site
city: Stubicke toplice
country: Croatia
facility: Research Site
city: Umag
country: Croatia
facility: Research Site
city: Vinkovci
country: Croatia
facility: Research Site
city: Virovitica- Slatina
country: Croatia
facility: Research Site
city: Virovitica
country: Croatia
facility: Research Site
city: Vukovar
country: Croatia
facility: Research Site
city: Zadar
country: Croatia
facility: Research Site
city: Zageb
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Svjetlana Serdar
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Karin Otter
role: STUDY_DIRECTOR
References: