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

Russian Cardiology Research and Production Center

Status: Completed

Conditions: Cardiovascular Diseases; Coronary Disease

Treatments: Procedure: coronary artery bypass grafting; Procedure: percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02515747

01200406198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,400 participants in 3 patient groups

conservative treatment

No Intervention group

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

percutaneous coronary intervention

Active Comparator group

Description:

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

Treatment:

Procedure: percutaneous coronary intervention

coronary artery bypass grafting

Active Comparator group

Description:

elective surgery myocardial revascularisation on the basement of drugs treatment

Treatment:

Procedure: coronary artery bypass grafting