Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01257971

Enrollment

1868

Registered

2010-12-10

Start date

2011-01-31

Completion date

2011-10-31

Last updated

2012-03-20

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

Conditions

Hypercholesterolaemia

Keywords

Cholesterol, HMG-CoA reductase inhibitor, cardiovascular risk, LDLl

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.

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 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.

Design outcomes

Primary

Measure	Time frame
Number 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
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
Number 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
Number 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
Number 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
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
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
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

Croatia

Outcome results