Coronary DiseasePRELUDENCT02515747
Prospective Russian Evaluation of Lp(a) Role in cardiovascUlar DiseasE
A study testing percutaneous coronary intervention and coronary artery bypass grafting in people with Coronary Disease and Cardiovascular Diseases, run by Russian Cardiology Research and Production Center.
Trial summary
The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a) phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease patients divided on the basis of management strategy - medical, endovascular or open cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Cardiovascular Diseases
- What is being tested?
- percutaneous coronary intervention and coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- Jan 1993to Jan 2014
- Phase
- Interventional
- 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
Who may be able to join
- stable coronary heart disease verified by angiography
Who cannot join
- acute coronary syndromes,
- acute infections,
- inflammatory disease within 3 months prior to inclusion,
- familial hypercholesterolemia,
- triglycerides>4.5 mmol/L,
- missing Lp(a) measurements
About this study
Official title: Role of Lipoprotein(a) Concentration and Apolipoprotein(a) Phenotype in Prediction of Coronary Events in General Population
The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a) phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease patients divided on the basis of management strategy - medical, endovascular or open cardiac surgery.
Read the detailed description
Between January 1993 and September 2006, we enrolled 1400 consecutive patients from the Atherosclerosis Department with known Lp(a) levels and coronary heart disease (CHD) verified by angiography. In accordance with clinical condition and angiography data were assigned them into three parallel treatment arms and followed up to 15 years. This study was conducted according to the principles of the Declaration of Helsinki and the Institutional Ethics Committee.
- Conditions
- Coronary Disease, Cardiovascular Diseases
- Being tested
- percutaneous coronary intervention, coronary artery bypass grafting
- Keywords
- Lipoprotein(a), coronary artery bypass grafting (CABG), apo(a), prognosis, myocardial infarction, cardiovascular death, percutaneous coronary intervention (PCI)
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
elective percutaneous coronary balloon angioplasty and/or stenting
coronary artery bypass graftingProcedure or surgery
elective surgical myocardial revascularisation
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | No intervention | Men and women with stable CHD verified by angiography from one center and allocated to three treatment arms in real-world practice: 1. conservative treatment with statins, antiaggregants, antianginal drugs in standard dosage |
| percutaneous coronary intervention | Active comparator | 2. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment Receives: Procedure: percutaneous coronary intervention |
| coronary artery bypass grafting | Active comparator | elective surgery myocardial revascularisation on the basement of drugs treatment Receives: Procedure: coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-fatal myocardial infarction and cardiovascular death
we took a composite primary outcome measure because anticipated a low number of hard-end-points in each treatment arm
Measured: up to 15 years
Secondary outcomes (1)
non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina
we chose a composite secondary outcome mesure as a standard for such type studies and to obtain a statistical difference between the groups
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJan 1993
- Primary completionSep 2006
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Cardiology Research and Production Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marat Vladislavovich Ezhov (MV Ezhov, MD, PhD, DMSc), Russian Cardiology Research and Production Center
- Investigators
- Marat V. Ezhov, PhD, DMSc, Principal investigator, Russian Cardiology Research and Production CenterSergei N. Pokrovsky, PhD, DSc, Study chair, Russian Cardiology Research and Production CenterValery V. Kukharchuk, PhD, DMSc, Study chair, Russian Cardiology Research and Production Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515747
- Sponsor's protocol ID
- 01200406198
- Acronym
- PRELUDE
- Status last verified
- Aug 2015
- First submitted
- 8 May 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ezhov MV, Afanas'eva OI, Kambegova AA, Afanas'eva MI, Trukhacheva EP, Naumov VG, Pokrovskii SN. [The role of atherosclerosis risk factors in development of ischemic heart disease in young men]. Ter Arkh. 2009;81(5):50-4. Russian.
PubMed 19537587Ezhov MV, Liakishev AA, Pokrovskii SN. [Lipoprotein (a) - an independent risk factor in atherosclerosis]. Ter Arkh. 2001;73(9):76-82. No abstract available. Russian.
PubMed 11642088Pokrovsky SN, Ezhov MV, Il'ina LN, Afanasieva OI, Sinitsyn VY, Shiriaev AA, Akchurin RS. Association of lipoprotein(a) excess with early vein graft occlusions in middle-aged men undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2003 Oct;126(4):1071-5. doi: 10.1016/s0022-5223(03)00365-9.
PubMed 14566249Ezhov MV, Safarova MC, Afanas'eva OI, Il'ina LN, Liakishev AA, Pokrovskii SN. [High level of lipoprotein (a) as a predictor of poor long-term prognosis after coronary artery bypass surgery]. Kardiologiia. 2011;51(1):18-22. Russian.
PubMed 21626797Ezhov MV, Safarova MS, Afanasieva OI, Kukharchuk VV, Pokrovsky SN. Lipoprotein(a) level and apolipoprotein(a) phenotype as predictors of long-term cardiovascular outcomes after coronary artery bypass grafting. Atherosclerosis. 2014 Aug;235(2):477-82. doi: 10.1016/j.atherosclerosis.2014.05.944. Epub 2014 Jun 4.
PubMed 24952151Britareva VV, Afanas'eva OI, Dobrovol'skii AB, Ezhov MV, Titaeva EV, Karpov IuA, Pokrovskii SN. [Lipoprotein(a) and Apo-A isoforms in patients with intermittent claudication]. Ter Arkh. 2002;74(12):49-52. Russian.
PubMed 12577841Ezhov MV, Afanas'eva OI, Benevolenskaia GF, Savchenko AP, Balakhonova TV, Liakishev AA, Pokrovskii SN. [Association of lipoprotein(a) and apolipoprotein(a) phenotypes with coronary and carotid atherosclerosis in CHD men]. Ter Arkh. 2000;72(1):28-32. Russian.
PubMed 10687202Ezhov MV, Afanas'ev OI, Benevolenskaia GF, Savchenko AP, Liakishev AA, Pokrovskii SN. [Lipoprotein(a) as a biochemical marker of coronary atherosclerosis]. Ter Arkh. 1997;69(9):31-4. Russian.
PubMed 9411822Safarova MS, Trukhacheva EP, Ezhov MV, Afanas'eva OI, Afanas'eva MI, Tripoten' MI, Liakishev AA, Pokrovskii SN. [Pleiotropic effects of nicotinic acid therapy in men with coronary heart disease and elevated lipoprotein(a) levels]. Kardiologiia. 2011;51(5):9-16. Russian.
PubMed 21649590
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lipoprotein(a) Concentration and Apolipoprotein(a) Phenotype in Prediction of Coronary Events in General Population
- ClinicalTrials.gov ID
- NCT02515747
- Acronym / sponsor ID
- PRELUDE / 01200406198
- Conditions
- Coronary Disease, Cardiovascular Diseases
- Keywords
- Lipoprotein(a), coronary artery bypass grafting (CABG), apo(a), prognosis, myocardial infarction, cardiovascular death, percutaneous coronary intervention (PCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Russian Cardiology Research and Production CenterUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Sep 2006 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Aug 2015 (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 this study is to explore the role of lipoprotein(a) and apolipoprotein(a) phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease patients divided on the basis of management strategy - medical, endovascular or open cardiac surgery.
Detailed description
Between January 1993 and September 2006, we enrolled 1400 consecutive patients from the Atherosclerosis Department with known Lp(a) levels and coronary heart disease (CHD) verified by angiography. In accordance with clinical condition and angiography data were assigned them into three parallel treatment arms and followed up to 15 years. This study was conducted according to the principles of the Declaration of Helsinki and the Institutional Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | No intervention | –Men and women with stable CHD verified by angiography from one center and allocated to three treatment arms in real-world practice: 1. conservative treatment with statins, antiaggregants, antianginal drugs in standard dosage |
| percutaneous coronary intervention | Active comparator | Procedure: percutaneous coronary intervention2. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment |
| coronary artery bypass grafting | Active comparator | Procedure: coronary artery bypass graftingelective surgery myocardial revascularisation on the basement of drugs treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable coronary heart disease verified by angiography
Key exclusion criteria (6 listed)
- acute coronary syndromes,
- acute infections,
- inflammatory disease within 3 months prior to inclusion,
- familial hypercholesterolemia,
- triglycerides>4.5 mmol/L,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary interventionelective percutaneous coronary balloon angioplasty and/or stenting | Procedure or surgery | percutaneous coronary intervention |
| coronary artery bypass graftingelective surgical myocardial revascularisation | Procedure or surgery | coronary artery bypass grafting |
Primary outcome
non-fatal myocardial infarction and cardiovascular death
Time frame: up to 15 years
we took a composite primary outcome measure because anticipated a low number of hard-end-points in each treatment arm
1 secondary outcome
non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina
Time frame: up to 15 years
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 5 Aug 2015.
- Background: PubMed 19537587Ezhov MV, Afanas'eva OI, Kambegova AA, Afanas'eva MI, Trukhacheva EP, Naumov VG, Pokrovskii SN. [The role of atherosclerosis risk factors in development of ischemic heart disease in young men]. Ter Arkh. 2009;81(5):50-4. Russian.
- Background: PubMed 11642088Ezhov MV, Liakishev AA, Pokrovskii SN. [Lipoprotein (a) - an independent risk factor in atherosclerosis]. Ter Arkh. 2001;73(9):76-82. No abstract available. Russian.
- Results publication: PubMed 14566249Pokrovsky SN, Ezhov MV, Il'ina LN, Afanasieva OI, Sinitsyn VY, Shiriaev AA, Akchurin RS. Association of lipoprotein(a) excess with early vein graft occlusions in middle-aged men undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2003 Oct;126(4):1071-5. doi: 10.1016/s0022-5223(03)00365-9.
- Results publication: PubMed 21626797Ezhov MV, Safarova MC, Afanas'eva OI, Il'ina LN, Liakishev AA, Pokrovskii SN. [High level of lipoprotein (a) as a predictor of poor long-term prognosis after coronary artery bypass surgery]. Kardiologiia. 2011;51(1):18-22. Russian.
- Results publication: PubMed 24952151Ezhov MV, Safarova MS, Afanasieva OI, Kukharchuk VV, Pokrovsky SN. Lipoprotein(a) level and apolipoprotein(a) phenotype as predictors of long-term cardiovascular outcomes after coronary artery bypass grafting. Atherosclerosis. 2014 Aug;235(2):477-82. doi: 10.1016/j.atherosclerosis.2014.05.944. Epub 2014 Jun 4.
- Results publication: PubMed 12577841Britareva VV, Afanas'eva OI, Dobrovol'skii AB, Ezhov MV, Titaeva EV, Karpov IuA, Pokrovskii SN. [Lipoprotein(a) and Apo-A isoforms in patients with intermittent claudication]. Ter Arkh. 2002;74(12):49-52. Russian.
- Results publication: PubMed 10687202Ezhov MV, Afanas'eva OI, Benevolenskaia GF, Savchenko AP, Balakhonova TV, Liakishev AA, Pokrovskii SN. [Association of lipoprotein(a) and apolipoprotein(a) phenotypes with coronary and carotid atherosclerosis in CHD men]. Ter Arkh. 2000;72(1):28-32. Russian.
- Results publication: PubMed 9411822Ezhov MV, Afanas'ev OI, Benevolenskaia GF, Savchenko AP, Liakishev AA, Pokrovskii SN. [Lipoprotein(a) as a biochemical marker of coronary atherosclerosis]. Ter Arkh. 1997;69(9):31-4. Russian.
- Results publication: PubMed 21649590Safarova MS, Trukhacheva EP, Ezhov MV, Afanas'eva OI, Afanas'eva MI, Tripoten' MI, Liakishev AA, Pokrovskii SN. [Pleiotropic effects of nicotinic acid therapy in men with coronary heart disease and elevated lipoprotein(a) levels]. Kardiologiia. 2011;51(5):9-16. Russian.
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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.
Marat V. Ezhov, PhD, DMSc principal investigator
Russian Cardiology Research and Production Center
Sergei N. Pokrovsky, PhD, DSc study chair
Russian Cardiology Research and Production Center
Valery V. Kukharchuk, PhD, DMSc study chair
Russian Cardiology Research and Production Center
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous coronary intervention and coronary artery bypass grafting in people with Coronary Disease and Cardiovascular Diseases, run by Russian Cardiology Research and Production Center.
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 1 inclusion and 6 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 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
non-fatal myocardial infarction and cardiovascular death (time frame: up to 15 years). 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 NCT02515747, which also lists 9 linked publications.
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 5 Aug 2015.