Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)OPTIMAIINCT02099565
Observational Prospective Study OPTIMA II - Follow-up
An observational study of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), run by AstraZeneca at 1 site in Russia.
Trial summary
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study. Read more about this study
- Who is it for?
- Ages 18 to 150 years
- Conditions the study is for
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
- How many people
- 572 participants
- Where
- 1 siteRussia
- Study dates
- May 2014to Apr 2015
- 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 to 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Follow-up OPTIMA (NIS-GRU-NEX-2009/) study patients
Who may be able to join
- Participation in OPTIMA study;
- Written informed consent provided prior the start of follow-up in the study
Who cannot join
- Lost to follow-up patients of OPTIMA study;
- Subjects who are unwilling or unable to provide informed consent.
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 (Percutaneuos Coronary Intervention) With Drug Eluting Stent (DES) Implantation Who Take Statins (OPTIMA II) - Follow-up
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study. In addition, the long-term effects of statins on LDL-cholesterol and different biomarkers in patients after drug-eluting stents implantation will be assessed. In addition, such project implementation will allow to clarify the treatment options used by Russian patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The information received in this study will help to optimize management of Russian patients with CAD after PCI in order to improve prognosis and quality of life of these patients.
Read the detailed description
This project is 3-years follow-up of OPTIMA study. This is an observational retro-prospective study based on the data collected during one visit: 4-year after PCI performed at the Russian Cardiological Research Center (РКНПК). From the date of the study start and until the end of the study investigators will enroll those patients participated in OPTIMA study. Only patients, who consent to participate in the study and sign the informed consent form after being informed by a physician on the objectives and methods of the study, will be enrolled into this project.
This study is an observational one, and there is no intervention into routine clinical practice either in terms of therapy, or special examinations. The main point of this project is the data collection using the out-patient medical records or disease history of a patient, as well as collection of data received during patient routine examination. Data collection will be performed only once during single routine patient visit to treating physician or hospitalized patient examination. Study participation will be finished after this visit. Data collection will be performed at the visit 4 years after PCI and will include medical history, current medications, physical examination, ECG (electrocardiogram) and laboratory assessments.
The study will be conducted in Russian Federation. It is planned that 80-90% of patients participated in OPTIMA study will be enrolled into current project. One clinical site - Russian Cardiological Research Center (РКНПК) - is supposed to participate in this study.
The total period of the study is anticipated to be about 18 months.
- Keywords
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), Statins, LDL-cholesterol, Inflammatory markers, Percutaneous Coronary Intervention (PCI)
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 |
|---|---|---|
| OPTIMA study patients | The study population will consist of OPTIMA study patients who have not been lost for follow-up and have given a written informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) in patients after drug-eluting stents (DES) implantation who takes statins at baseline after 4 years after PCI (Percutaneuos Coronary Intervention).
The rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) in patients after drug-eluting stents (DES) implantation who take statins at baseline after 4 years after PCI.
Measured: from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)
Secondary outcomes (7)
The proportion of patients who take statins during 4 years after PCI and who discontinue statin therapy.
The proportion of patients who take statins during 4 years after PCI and who discontinue statin therapy.
Measured: Up to 4 years after PCI
The proportion of patients who achieve target level of Low Density Lipoprotein Cholesterol (LDL-C) less than 1,8 mmol/l.
The proportion of patients who achieve target level of Low Density Lipoprotein Cholesterol (LDL-C) less than 1,8 mmol/l.
Measured: from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)
LDL-C level.
LDL-C level.
Measured: from 31 March 2014 to 31 March 2015
Lipoprotein A level.
Lipoprotein A level.
Measured: from 31 March 2014 to 31 March 2015
To estimate adherence to the therapy with statins according to questionnaire based on results of questionnaire
To estimate adherence to the therapy with statins according to questionnaire based on results of questionnaire
Measured: Up to 4 years after PCI
To evaluate proportion of patients who discontinue statin therapy, beta-blockers and ACE (Angiotensin Converting Enzyme) inhibitors therapy and identify their characteristics based on results of questionnaires and CRFs (Case Report Forms)
To evaluate proportion of patients who discontinue statin therapy, beta-blockers and ACE inhibitors therapy and identify their characteristics based on results of questionnaires and CRFs
Measured: Up to 4 years after PCI
To estimate Seattle angina questionnaire (SAQ) score 4 years after PCI
To estimate Seattle angina questionnaire (SAQ) score 4 years after PCI
Measured: from 1 Jul 2015 to 30 Sep 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)Studies 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
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karin Otter, PHD, MD, Study director, AstraZenecaYuri Karpov, Principal investigator, Russian Cardiology Research and Production Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099565
- Sponsor's protocol ID
- NIS-CRU-CRE-2014/1
- Acronym
- OPTIMAII
- Status last verified
- Feb 2016
- First submitted
- 25 Mar 2014
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Karpov Y, Logunova N, Tomilova D, Buza V, Khomitskaya Y. Observational Prospective study to esTIMAte the rates of outcomes in patients undergoing PCI with drug-eluting stent implantation who take statins -follow-up (OPTIMA II). Curr Med Res Opin. 2017 Feb;33(2):253-259. doi: 10.1080/03007995.2016.1253552. Epub 2016 Nov 29.
PubMed 27779436
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. 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 (Percutaneuos Coronary Intervention) With Drug Eluting Stent (DES) Implantation Who Take Statins (OPTIMA II) - Follow-up
- ClinicalTrials.gov ID
- NCT02099565
- Acronym / sponsor ID
- OPTIMAII / NIS-CRU-CRE-2014/1
- Keywords
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), Statins, LDL-cholesterol, Inflammatory markers, Percutaneous Coronary Intervention (PCI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Mar 2014 (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 current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study. In addition, the long-term effects of statins on LDL-cholesterol and different biomarkers in patients after drug-eluting stents implantation will be assessed. In addition, such project implementation will allow to clarify the treatment options used by Russian patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The information received in this study will help to optimize management of Russian patients with CAD after PCI in order to improve prognosis and quality of life of these patients.
Detailed description
This project is 3-years follow-up of OPTIMA study. This is an observational retro-prospective study based on the data collected during one visit: 4-year after PCI performed at the Russian Cardiological Research Center (РКНПК). From the date of the study start and until the end of the study investigators will enroll those patients participated in OPTIMA study. Only patients, who consent to participate in the study and sign the informed consent form after being informed by a physician on the objectives and methods of the study, will be enrolled into this project.
This study is an observational one, and there is no intervention into routine clinical practice either in terms of therapy, or special examinations. The main point of this project is the data collection using the out-patient medical records or disease history of a patient, as well as collection of data received during patient routine examination. Data collection will be performed only once during single routine patient visit to treating physician or hospitalized patient examination. Study participation will be finished after this visit. Data collection will be performed at the visit 4 years after PCI and will include medical history, current medications, physical examination, ECG (electrocardiogram) and laboratory assessments.
The study will be conducted in Russian Federation. It is planned that 80-90% of patients participated in OPTIMA study will be enrolled into current project. One clinical site - Russian Cardiological Research Center (РКНПК) - is supposed to participate in this study.
The total period of the study is anticipated to be about 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPTIMA study patients | – | –The study population will consist of OPTIMA study patients who have not been lost for follow-up and have given a written informed consent. |
Who may qualify
- Ages
- 18 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Follow-up OPTIMA (NIS-GRU-NEX-2009/) study patients
Key inclusion criteria (2 listed)
- Participation in OPTIMA study;
- Written informed consent provided prior the start of follow-up in the study
Key exclusion criteria (2 listed)
- Lost to follow-up patients of OPTIMA study;
- Subjects who are unwilling or unable to provide informed consent.
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
The rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) in patients after drug-eluting stents (DES) implantation who takes statins at baseline after 4 years after PCI (Percutaneuos Coronary Intervention).
Time frame: from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)
The rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) in patients after drug-eluting stents (DES) implantation who take statins at baseline after 4 years after PCI.
7 secondary outcomes
The proportion of patients who take statins during 4 years after PCI and who discontinue statin therapy.
Time frame: Up to 4 years after PCI
The proportion of patients who achieve target level of Low Density Lipoprotein Cholesterol (LDL-C) less than 1,8 mmol/l.
Time frame: from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)
LDL-C level.
Time frame: from 31 March 2014 to 31 March 2015
Lipoprotein A level.
Time frame: from 31 March 2014 to 31 March 2015
To estimate adherence to the therapy with statins according to questionnaire based on results of questionnaire
Time frame: Up to 4 years after PCI
To evaluate proportion of patients who discontinue statin therapy, beta-blockers and ACE (Angiotensin Converting Enzyme) inhibitors therapy and identify their characteristics based on results of questionnaires and CRFs (Case Report Forms)
Time frame: Up to 4 years after PCI
To estimate Seattle angina questionnaire (SAQ) score 4 years after PCI
Time frame: from 1 Jul 2015 to 30 Sep 2015
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 25 Feb 2016.
- Derived from this study: PubMed 27779436Karpov Y, Logunova N, Tomilova D, Buza V, Khomitskaya Y. Observational Prospective study to esTIMAte the rates of outcomes in patients undergoing PCI with drug-eluting stent implantation who take statins -follow-up (OPTIMA II). Curr Med Res Opin. 2017 Feb;33(2):253-259. doi: 10.1080/03007995.2016.1253552. Epub 2016 Nov 29.
- CSR synopsis for OPTIMA II NIS studyLink provided by the sponsor.
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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.
Karin Otter, PHD, MD study director
AstraZeneca
Yuri Karpov principal investigator
Russian Cardiology Research and Production Complex
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 Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), 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 2 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: finished, as of the sponsor's last update on 25 Feb 2016. 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?
The rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) in patients after drug-eluting stents (DES) implantation who takes statins at baseline after 4 years after PCI (Percutaneuos Coronary Intervention). (time frame: from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)). 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 NCT02099565, which also lists 1 linked publication.
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 25 Feb 2016.