DyslipidaemiaSTEPNCT01055977

Statin Therapy Results in the Real World Practice in the Czech Republic

An observational study of Dyslipidaemia, run by AstraZeneca at 95 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Statins are the first choice treatment of dyslipidemia, a major contributor to cardiovascular diseases. Statins also have enough evidence to demonstrate decrease of morbidity and mortality from cardiovascular diseases. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidaemia
How many people: 3,253 participants
Where: 95 sitesCzechia
Study dates: Feb 2010to Jun 2010
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: specialist care clinics

Who may be able to join

Documented statin therapy for at least 12 months
Available two LDL-C values: one at the beginning of statin therapy or at the time when patient comes to a specialist; and the other one at least after 12 months of treatment. The latter value should not be older than 6 months.

Who cannot join

Trial locations and contacts

95 sites in 1 country.

City, postcode or hospital

95 sites in 1 country

Czechia95 sites

Research Site
Benešov
Research Site
Beroun
Research Site
Blansko
Research Site
Bohumín
Research Site
Boskovice
Research Site
Brandýs nad Labem
Research Site
Brno
Research Site
Česká Lípa
Research Site
České Budějovice
Research Site
Český Krumlov
Research Site
Cheb
Research Site
Chomutov
Research Site
Chrudim
Research Site
Děčín
Research Site
Domažlice
Research Site
Dvůr Králové nad Labem
Research Site
Frýdek-Místek
Research Site
Fryštát
Research Site
Havířov
Research Site
Havlíčkův Brod
Research Site
Hradec Králové
Research Site
Hustopeče
Research Site
Ivančice
Research Site
Jablonec nad Nisou
Research Site
Jeseník
Research Site
Jičín
Research Site
Jihlava
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Jindřichův Hradec
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Karlovy Vary
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Kladno
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Kolín
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Krnov
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Kuřim
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Kutná Hora
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Kyjov
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Liberec
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Litoměřice
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Louny
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Mělník
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Městec Králové
Research Site
Mikulov
Research Site
Milevsko
Research Site
Mladá Boleslav
Research Site
Moravská Třebová
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Moravské Budějovice
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Moravský Krumlov
Research Site
Most
Research Site
Náchod
Research Site
Nový Bydžov
Research Site
Olomouc
Research Site
Opava
Research Site
Orlová
Research Site
Ostrava
Research Site
Ostrov
Research Site
Pardubice
Research Site
Pelhřimov
Research Site
Pilsen
Research Site
Písek
Research Site
Police nad Metují
Research Site
Polička
Research Site
Prachatice
Research Site
Prague
Research Site
Přerov
Research Site
Přeštice
Research Site
Příbram
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Prostějov
Research Site
Rakovník
Research Site
Roudnice nad Labem
Research Site
Rožnov pod Radhoštěm
Research Site
Rychnov nad Kněžnou
Research Site
Semily
Research Site
Slaný
Research Site
Smiřice
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Sternberk
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Strakonice
Research Site
Sušice
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Svitavy
Research Site
Tábor
Research Site
Teplice
Research Site
Tišnov
Research Site
Třebíč
Research Site
Třinec
Research Site
Trutnov
Research Site
Turnov
Research Site
Uherské Hradiště
Research Site
Ústí nad Labem
Research Site
Valašské Klobouky
Research Site
Veselí nad Moravou
Research Site
Vítkovice
Research Site
Vsetín
Research Site
Vyškov
Research Site
Vysoké Mýto
Research Site
Žamberk
Research Site
Zlín
Research Site
Znojmo

Other trials in Czechia

About this study

The aim of the study is to estimate proportion of patients who achieved the therapeutic goal (LDL-C. total cholesterol, HDL-C and triglycerides levels) after at least one year of a statin therapy.

Conditions: Dyslipidaemia
Keywords: statin therapy, treatment goal, dyslipidaemia
Medical subject headings: Dyslipidemias

What is being measured

The primary outcome is the main question the study is designed to answer.

LDL-C
Measured: one year

Secondary outcomes (3)

Total cholesterol
Measured: one year
HDL-C
Measured: one year
triglycerides
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Jun 2010

First posted26 Jan 2010 (estimated)
Study startFeb 2010
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DyslipidaemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Retrospective
Enrolment: 3,253 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01055977
Sponsor's protocol ID: NIS-CCZ-CRE-2009/1
Acronym: STEP
Status last verified: Aug 2011
First submitted: 25 Jan 2010
Last updated: 30 Aug 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

All Dyslipidaemia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Statin Therapy Results in the Real World Practice in the Czech Republic
ClinicalTrials.gov ID: NCT01055977
Acronym / sponsor ID: STEP / NIS-CCZ-CRE-2009/1
Conditions: Dyslipidaemia
Keywords: statin therapy, treatment goal, dyslipidaemia
Study type: Observational
Recruitment status: Completed
Enrolment: 3,253 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 26 Jan 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of the study is to estimate proportion of patients who achieved the therapeutic goal (LDL-C. total cholesterol, HDL-C and triglycerides levels) after at least one year of a statin therapy.

Study design

Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: specialist care clinics

Key inclusion criteria (2 listed)

Documented statin therapy for at least 12 months
Available two LDL-C values: one at the beginning of statin therapy or at the time when patient comes to a specialist; and the other one at least after 12 months of treatment. The latter value should not be older than 6 months.

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

LDL-C
Time frame: one year

3 secondary outcomes

Total cholesterol
Time frame: one year
HDL-C
Time frame: one year
triglycerides
Time frame: one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.

Related trials for Dyslipidaemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ales Kminek study director

AstraZeneca

Jaromir Hradec principal investigator

General faculty hospital Prague

Jan Bultas principal investigator

Faculty hospital Kralovske Vinohrady Prague

95 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dyslipidaemia, run by AstraZeneca at 95 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01055977.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.