DyslipidemiaOPTIMANCT01047176
Observational Study to Estimate the Rates of Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI) With Drug Eluting Stent (DES) Implantation Who Take Statins
An observational study of Dyslipidemia and Coronary Heart Disease, run by AstraZeneca at 1 site in Russia.
Trial summary
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Coronary Heart Disease
- How many people
- 602 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2009to Dec 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: Hospital patient
Who may be able to join
- Stable angina with indication to PCI
- Hospitalization to Russian Cardiological Research Center (РКНПК) for PCI procedure with drug-eluting stents implantation
- Statin therapy initiated for at least one month prior to PCI
- Written informed consent provided prior the start of participation in the study.
Who cannot join
- Subjects who are unwilling or unable to provide informed consent.
- Presence of ACS during the current hospitalization
- Severe CHF (NYHA III/IV) or LVEF<40 %
- Stroke within 6 months before PCI
- Acute or chronic inflammatory disease
- Anti-inflammatory medications intake, with the exception of aspirin
Show all 10Show fewer
- Severe liver or muscle disease
- Severe kidney disease / renal failure with creatinine > 3 mg/dl
- History of oncologic disease
- Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI With Drug Eluting Stent (DES) Implantation Who Take Statins
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
- Conditions
- Dyslipidemia, Coronary Heart Disease
- Keywords
- Statins, Coronary Heart Disease, Percutaneous coronary intervention (PCI)
- Medical subject headings
- Dyslipidemias, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Male or female > 18 year of age with indication to PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
Measured: 3 visits for 12 month (before and after PCI)
Secondary outcomes (6)
To evaluate prognostic factors (demographic, co-morbidity, smoking, LDL-C, inflammatory and cardiac markers) in patients undergoing PCI with drug eluting stent (DES) implantation who take statins and their association with PCI (MACCE) outcomes
Measured: 3 visits for 12 month
To estimate Low Density Lipoprotein Cholesterol (LDL-C) target level achievement and lipid-lowering therapy details in patients taking standard lipid lowering therapy prior the PCI.
Measured: 3 visits for 12 months
To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI.
Measured: 3 visits for 12 months
To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.
Measured: 3 visits for 12 months
To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome.
Measured: 3 visits for 12 months
To study the rate of early and late stent thrombosis according to ARC classification
Measured: 3 visits for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuri A Karpov, Principal investigator, RCRC (РКНПК)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047176
- Sponsor's protocol ID
- NIS-CRU-CRE-2009/1
- Acronym
- OPTIMA
- Status last verified
- Feb 2012
- First submitted
- 11 Jan 2010
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI With Drug Eluting Stent (DES) Implantation Who Take Statins
- ClinicalTrials.gov ID
- NCT01047176
- Acronym / sponsor ID
- OPTIMA / NIS-CRU-CRE-2009/1
- Conditions
- Dyslipidemia, Coronary Heart Disease
- Keywords
- Statins, Coronary Heart Disease, Percutaneous coronary intervention (PCI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 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.
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Male or female > 18 year of age with indication to PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patient
Key inclusion criteria (4 listed)
- Stable angina with indication to PCI
- Hospitalization to Russian Cardiological Research Center (РКНПК) for PCI procedure with drug-eluting stents implantation
- Statin therapy initiated for at least one month prior to PCI
- Written informed consent provided prior the start of participation in the study.
Key exclusion criteria (10 listed)
- Subjects who are unwilling or unable to provide informed consent.
- Presence of ACS during the current hospitalization
- Severe CHF (NYHA III/IV) or LVEF<40 %
- Stroke within 6 months before PCI
- Acute or chronic inflammatory disease
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
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
Time frame: 3 visits for 12 month (before and after PCI)
6 secondary outcomes
To evaluate prognostic factors (demographic, co-morbidity, smoking, LDL-C, inflammatory and cardiac markers) in patients undergoing PCI with drug eluting stent (DES) implantation who take statins and their association with PCI (MACCE) outcomes
Time frame: 3 visits for 12 month
To estimate Low Density Lipoprotein Cholesterol (LDL-C) target level achievement and lipid-lowering therapy details in patients taking standard lipid lowering therapy prior the PCI.
Time frame: 3 visits for 12 months
To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI.
Time frame: 3 visits for 12 months
To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.
Time frame: 3 visits for 12 months
To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome.
Time frame: 3 visits for 12 months
To study the rate of early and late stent thrombosis according to ARC classification
Time frame: 3 visits for 12 months
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 1 Mar 2012.
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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.
Yuri A Karpov principal investigator
RCRC (РКНПК)
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 Dyslipidemia and Coronary Heart Disease, run by AstraZeneca at 1 site in Russia.
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 4 inclusion and 10 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 1 Mar 2012. 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 Russia. 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?
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins. (time frame: 3 visits for 12 month (before and after PCI)). 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 1 Mar 2012.