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Prospective Russian Evaluation of Lp(a) Role in cardiovascUlar DiseasE (PRELUDE)

Primary Purpose

Coronary Disease, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
percutaneous coronary intervention
coronary artery bypass grafting
Sponsored by
Russian Cardiology Research and Production Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Lipoprotein(a), coronary artery bypass grafting (CABG), apo(a), prognosis, myocardial infarction, cardiovascular death, percutaneous coronary intervention (PCI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stable coronary heart disease verified by angiography

Exclusion Criteria:

  • acute coronary syndromes,
  • acute infections,
  • inflammatory disease within 3 months prior to inclusion,
  • familial hypercholesterolemia,
  • triglycerides>4.5 mmol/L,
  • missing Lp(a) measurements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    conservative treatment

    percutaneous coronary intervention

    coronary artery bypass grafting

    Arm Description

    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

    2. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment

    elective surgery myocardial revascularisation on the basement of drugs treatment

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    May 8, 2015
    Last Updated
    August 1, 2015
    Sponsor
    Russian Cardiology Research and Production Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02515747
    Brief Title
    Prospective Russian Evaluation of Lp(a) Role in cardiovascUlar DiseasE
    Acronym
    PRELUDE
    Official Title
    Role of Lipoprotein(a) Concentration and Apolipoprotein(a) Phenotype in Prediction of Coronary Events in General Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1993 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Russian Cardiology Research and Production Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Disease, Cardiovascular Diseases
    Keywords
    Lipoprotein(a), coronary artery bypass grafting (CABG), apo(a), prognosis, myocardial infarction, cardiovascular death, percutaneous coronary intervention (PCI)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conservative treatment
    Arm Type
    No Intervention
    Arm Description
    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
    Arm Title
    percutaneous coronary intervention
    Arm Type
    Active Comparator
    Arm Description
    2. elective balloon angioplasty alone or stent implanation on the basement of drugs treatment
    Arm Title
    coronary artery bypass grafting
    Arm Type
    Active Comparator
    Arm Description
    elective surgery myocardial revascularisation on the basement of drugs treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    percutaneous coronary intervention
    Intervention Description
    elective percutaneous coronary balloon angioplasty and/or stenting
    Intervention Type
    Procedure
    Intervention Name(s)
    coronary artery bypass grafting
    Intervention Description
    elective surgical myocardial revascularisation
    Primary Outcome Measure Information:
    Title
    non-fatal myocardial infarction and cardiovascular death
    Description
    we took a composite primary outcome measure because anticipated a low number of hard-end-points in each treatment arm
    Time Frame
    up to 15 years
    Secondary Outcome Measure Information:
    Title
    non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina
    Description
    we chose a composite secondary outcome mesure as a standard for such type studies and to obtain a statistical difference between the groups
    Time Frame
    up to 15 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: stable coronary heart disease verified by angiography Exclusion Criteria: acute coronary syndromes, acute infections, inflammatory disease within 3 months prior to inclusion, familial hypercholesterolemia, triglycerides>4.5 mmol/L, missing Lp(a) measurements
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marat V. Ezhov, PhD, DMSc
    Organizational Affiliation
    Russian Cardiology Research and Production Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sergei N. Pokrovsky, PhD, DSc
    Organizational Affiliation
    Russian Cardiology Research and Production Center
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Valery V. Kukharchuk, PhD, DMSc
    Organizational Affiliation
    Russian Cardiology Research and Production Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19537587
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11642088
    Citation
    Ezhov 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 Reference
    background
    PubMed Identifier
    14566249
    Citation
    Pokrovsky 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 Reference
    result
    PubMed Identifier
    21626797
    Citation
    Ezhov 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 Reference
    result
    PubMed Identifier
    24952151
    Citation
    Ezhov 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 Reference
    result
    PubMed Identifier
    12577841
    Citation
    Britareva 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 Reference
    result
    PubMed Identifier
    10687202
    Citation
    Ezhov 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 Reference
    result
    PubMed Identifier
    9411822
    Citation
    Ezhov 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 Reference
    result
    PubMed Identifier
    21649590
    Citation
    Safarova 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.
    Results Reference
    result

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    Prospective Russian Evaluation of Lp(a) Role in cardiovascUlar DiseasE

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