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

Cardiovascular Diseases Clinical Trial

— PRELUDE  

Official title:

Role of Lipoprotein(a) Concentration and Apolipoprotein(a) Phenotype in Prediction of Coronary Events in General Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515747
• Other study ID #: 01200406198
• Status: Completed
• Phase: N/A
• First received: May 8, 2015
• Last updated: August 1, 2015
• Start date: January 1993
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Russian Cardiology Research and Production Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: January 2014
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease

Intervention

Procedure:
• percutaneous coronary intervention
elective percutaneous coronary balloon angioplasty and/or stenting
• coronary artery bypass grafting
elective surgical myocardial revascularisation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Russian Cardiology Research and Production Center

References & Publications (9)

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. — View 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. — View 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. Russi — View 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. — View Citation

Ezhov MV, Liakishev AA, Pokrovskii SN. [Lipoprotein (a) - an independent risk factor in atherosclerosis]. Ter Arkh. 2001;73(9):76-82. Review. Russian. — View 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. — View 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: — View 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 — View 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	up to 15 years	No