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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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

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Atherosclerosis Coronary Disease Carotid Artery Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Specific Lp(a) apheresis & Atorvastatin

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.

Group Type EXPERIMENTAL

Specific Lp(a) apheresis

Intervention Type PROCEDURE

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

Atorvastatin

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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"Lp(a) Lipopak" immunoadsorption columns

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No