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NCT Number: NCT01257971

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

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.

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Biograd na Moru, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  2. Percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Secondary outcomes

  1. Number of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  2. Number of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  3. Number of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  4. Percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  5. Percentage of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  6. Percentage of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.

    Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2010
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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