Coronary Artery DiseaseNCT01190072
Lipid-lowering Therapy for Secondary Prevention in Patients Undergoing Elective Percutaneous Coronary Intervention (PCI)
An observational study of Coronary Artery Disease, run by AstraZeneca at 1 site in Slovenia.
Trial summary
The purpose of the study is to follow the management of blood lipids in patients with planned percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10 weeks after the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 120 participants
- Where
- 1 siteSlovenia
- Study dates
- Sep 2010to Mar 2011
- 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: Secondary care clinic
Who may be able to join
- Male or nonpregnant female
- Coronary patient hospitalised for elective PCI
- Hypercholesterolaemia defined as LDL-C ≥ 2 mmol/L
Who cannot join
- Any chronic inflammatory condition
- Chronic anti-inflammatory pharmacotherapy (except low-dose ASA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LIPID-LOWERING THERAPY FOR SECONDARY PREVENTION IN PATIENTS UNDERGOING ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) A 10-week, Open-label, Non-interventional Study of Total Cholesterol/LDL-cholesterol Management in Real Life in Coronary Patients Hospitalised for Elective PCI
The purpose of the study is to follow the management of blood lipids in patients with planned percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10 weeks after the intervention.
- Conditions
- Coronary Artery Disease
- Keywords
- Blood lipids, percutaneous coronary intervention, lipid lowering treatment
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum total cholesterol concentration
Measured: Week 0
Serum total cholesterol concentration
Measured: Once during the time period between Week 6 and Week 10
Serum LDL cholesterol concentration
Measured: Week 0
Serum LDL cholesterol concentration
Measured: Once during the time period between Week 6 and Week 10
Secondary outcomes (3)
Proportion of patients achieving LDL-C < 2 mmol/L
Measured: Once during the time period between Week 6 and Week 10
Proportion of patients achieving total cholesterol < 4 mmol/L
Measured: Once during the time period between Week 6 and Week 10
Change of hsCRP levels from baseline
Measured: Once during the time period between Week 6 and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vojko Kanic, Principal investigator, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190072
- Sponsor's protocol ID
- NIS-CSI-DUM-2010/1
- Status last verified
- Jan 2013
- First submitted
- 26 Aug 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIPID-LOWERING THERAPY FOR SECONDARY PREVENTION IN PATIENTS UNDERGOING ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) A 10-week, Open-label, Non-interventional Study of Total Cholesterol/LDL-cholesterol Management in Real Life in Coronary Patients Hospitalised for Elective PCI
- ClinicalTrials.gov ID
- NCT01190072
- Acronym / sponsor ID
- NIS-CSI-DUM-2010/1
- Conditions
- Coronary Artery Disease
- Keywords
- Blood lipids, percutaneous coronary intervention, lipid lowering treatment
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Aug 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 purpose of the study is to follow the management of blood lipids in patients with planned percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10 weeks after the intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care clinic
Key inclusion criteria (3 listed)
- Male or nonpregnant female
- Coronary patient hospitalised for elective PCI
- Hypercholesterolaemia defined as LDL-C ≥ 2 mmol/L
Key exclusion criteria (2 listed)
- Any chronic inflammatory condition
- Chronic anti-inflammatory pharmacotherapy (except low-dose ASA)
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
Serum total cholesterol concentration
Time frame: Week 0
Serum total cholesterol concentration
Time frame: Once during the time period between Week 6 and Week 10
Serum LDL cholesterol concentration
Time frame: Week 0
Serum LDL cholesterol concentration
Time frame: Once during the time period between Week 6 and Week 10
3 secondary outcomes
Proportion of patients achieving LDL-C < 2 mmol/L
Time frame: Once during the time period between Week 6 and Week 10
Proportion of patients achieving total cholesterol < 4 mmol/L
Time frame: Once during the time period between Week 6 and Week 10
Change of hsCRP levels from baseline
Time frame: Once during the time period between Week 6 and Week 10
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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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.
Vojko Kanic principal investigator
University Medical Centre Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by AstraZeneca at 1 site in Slovenia.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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 was stopped early. Results are not available in the source record.
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?
Serum total cholesterol concentration (time frame: Week 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2013.