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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02515747

Acronym

PRELUDE

Enrollment

1400

Registered

2015-08-05

Start date

1993-01-31

Completion date

2014-01-31

Last updated

2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Disease

Keywords

Lipoprotein(a), coronary artery bypass grafting (CABG), apo(a), prognosis, myocardial infarction, cardiovascular death, percutaneous coronary intervention (PCI)

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.

Interventions

PROCEDUREpercutaneous coronary intervention

elective percutaneous coronary balloon angioplasty and/or stenting

PROCEDUREcoronary artery bypass grafting

elective surgical myocardial revascularisation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
non-fatal myocardial infarction and cardiovascular death	up to 15 years	we took a composite primary outcome measure because anticipated a low number of hard-end-points in each treatment arm

Secondary

Measure	Time frame	Description
non-fatal myocardial infarction and cardiovascular death and myocardial revascularisation and hospitalization for recurrent or unstable angina	up to 15 years	we chose a composite secondary outcome mesure as a standard for such type studies and to obtain a statistical difference between the groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026