NCT02133807

Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis

A 72-week, Prospective, Parallel-group, Partially Blinded, Controlled Phase IIIb Study Evaluating the Impact of Specific Lp(a) Apheresis on Atherosclerotic Disease Burden in Coronary Heart Disease Patients With High Lipoprotein(a) Level.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Russian Cardiology Research and Production Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy could affect atherosclerotic disease burden in coronary and carotid arteries of coronary heart disease patients with elevated Lp(a) levels.

Detailed description

Following the hypothesis that if Lp(a) excess has a pathogenic role in atherogenesis, then specific elimination of circulating Lp(a) should affect plaque growth and stability, we evaluated the efficacy of Lp(a) apheresis on changes in coronary plaque volume and composition and carotid intima-media thickness in patients with CHD on the background of optimal medical treatment.

Conditions

• Atherosclerosis
• Coronary Disease
• Carotid Artery Diseases

Interventions

Type	Name	Description
PROCEDURE	Specific Lp(a) apheresis	Specific Lp(a) apheresis procedures were carried out weekly with "Lp(a) Lipopak" columns (POCARD Ltd., Moscow, Russia) according to the standard protocol

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2014-05-08
• Last updated: 2014-05-12

Locations

1 site across 1 country: Russia