NCT02515747

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1993

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1993

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

13.7 years

First QC Date

May 8, 2015

Last Update Submit

August 1, 2015

Conditions

Coronary DiseaseCardiovascular Diseases

Keywords

Lipoprotein(a)coronary artery bypass grafting (CABG)apo(a)prognosismyocardial infarctioncardiovascular deathpercutaneous coronary intervention (PCI)

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 15 years

Secondary Outcomes (1)

  • non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina

    up to 15 years

Study Arms (3)

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

Procedure: percutaneous coronary intervention

coronary artery bypass grafting

ACTIVE COMPARATOR

elective surgery myocardial revascularisation on the basement of drugs treatment

Procedure: coronary artery bypass grafting

Interventions

percutaneous coronary interventionPROCEDURE

elective percutaneous coronary balloon angioplasty and/or stenting

percutaneous coronary intervention
coronary artery bypass graftingPROCEDURE

elective surgical myocardial revascularisation

coronary artery bypass grafting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable coronary heart disease verified by angiography

You may not qualify if:

  • acute coronary syndromes,
  • acute infections,
  • familial hypercholesterolemia,
  • triglycerides\>4.5 mmol/L,
  • missing Lp(a) measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 19537587BACKGROUND

  • 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.

    PMID: 11642088BACKGROUND

  • 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.

    PMID: 14566249RESULT

  • 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.

    PMID: 21626797RESULT

  • 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.

    PMID: 24952151RESULT

  • 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.

    PMID: 12577841RESULT

  • 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.

    PMID: 10687202RESULT

  • 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.

    PMID: 9411822RESULT

  • 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.

    PMID: 21649590RESULT

MeSH Terms

Conditions

Coronary DiseaseCardiovascular DiseasesMyocardial Infarction

Interventions

Percutaneous Coronary InterventionCoronary Artery Bypass

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresMyocardial RevascularizationCardiac Surgical ProceduresVascular GraftingThoracic Surgical Procedures

Study Officials

  • Marat V. Ezhov, PhD, DMSc

    Russian Cardiology Research and Production Center

    PRINCIPAL INVESTIGATOR

  • Sergei N. Pokrovsky, PhD, DSc

    Russian Cardiology Research and Production Center

    STUDY CHAIR

  • Valery V. Kukharchuk, PhD, DMSc

    Russian Cardiology Research and Production Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dr.

Study Record Dates

First Submitted

May 8, 2015

First Posted

August 5, 2015

Study Start

January 1, 1993

Primary Completion

September 1, 2006

Study Completion

January 1, 2014

Last Updated

August 5, 2015

Record last verified: 2015-08