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

Russian Cardiology Research and Production Center

Status and phase: Completed; Phase 3

Conditions: Coronary Disease; Atherosclerosis; Carotid Artery Diseases

Treatments: Procedure: Specific Lp(a) apheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT02133807

01200953720

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable coronary heart disease (CHD) requiring a clinically indicated coronary angiography.
• Lp(a) ≥50 mg/dL
• LDL-C <2.6 mmol/L (100 mg/dL)
• Signed written informed consent form to participate in the study

Exclusion criteria

• history of acute coronary syndrome or surgical intervention within prior 3 months to inclusion
• chronic infectious and inflammatory diseases
• familial hypercholesterolemia
• TG ≥4.5 mmol/L (400 mg/dL)
• Active liver disease (ALT or AST >3 upper limit of normal (ULN), or total bilirubin >1.5 ULN);
• CK ≥3 ULN;
• Thyroid dysfunction;
• Renal dysfunction (creatinine clearance (Cockcroft-Gault Equation) ≤30 ml/min);
• Uncontrolled diabetes (HbA1c ≥7.0%);
• Coagulopathies;
• Lipid-lowering drugs, except statins for the last month
• Known statin or immunoadsorption intolerance

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Specific Lp(a) apheresis & Atorvastatin

Experimental group

Description:

Specific Lp(a) apheresis was performed with "Lp(a) Lipopak" immunosorbent columns ("POCARD" Ltd., Moscow, Russia) with sheep polyclonal monospecific antibodies against human Lp(a)/apo(a) weekly during 18 months. On the background - standard medical therapy in accordance with the recommendations for secondary prevention of CHD.

Treatment:

Procedure: Specific Lp(a) apheresis

Atorvastatin

No Intervention group

Description:

Standard medical therapy in accordance with the recommendations for secondary prevention of CHD