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
1 other identifier
observational
1,868
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Shorter than P25 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 10, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMarch 20, 2012
March 1, 2012
9 months
December 6, 2010
March 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
1
Patients with hypercholesterolaemia
Eligibility Criteria
Patients treated by specialist
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (27)
Research Site
Biograd na Moru, Croatia
Research Site
Bjelovar, Croatia
Research Site
Crikvenica, Croatia
Research Site
Čakovec, Croatia
Research Site
Dubrovnik, Croatia
Research Site
Gospić, Croatia
Research Site
Karlovac, Croatia
Research Site
Koprivnica, Croatia
Research Site
Krapina, Croatia
Research Site
Krapinske Toplice, Croatia
Research Site
Opatija, Croatia
Research Site
Osijek, Croatia
Research Site
Poreč, Croatia
Research Site
Pula, Croatia
Research Site
Rijeka, Croatia
Research Site
Sisak, Croatia
Research Site
Slavonski Brod, Croatia
Research Site
Split, Croatia
Research Site
Stubičke Toplice, Croatia
Research Site
Umag, Croatia
Research Site
Vinkovci, Croatia
Research Site
Virovitica, Croatia
Research Site
Virovitica- Slatina, Croatia
Research Site
Vukovar, Croatia
Research Site
Zadar, Croatia
Research Site
Zageb, Croatia
Research Site
Zagreb, Croatia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Svjetlana Serdar
AstraZeneca
- STUDY DIRECTOR
Karin Otter
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2010
First Posted
December 10, 2010
Study Start
January 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
March 20, 2012
Record last verified: 2012-03