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Completed

NCT Number: NCT02133807

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

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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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Russian Cardiology Research and Production Center

Moscow, 121552, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific Lp(a) apheresis

Procedure

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

Other names: "Lp(a) Lipopak" immunoadsorption columns

Primary outcomes

  1. Change in Percent Diameter Stenosis

    Time frame: From Baseline to End of Study (Week 72)

    The absolute change from baseline to 18 months in mean percent diameter stenosis, determined by quantitative coronary angiography (QCA) as the narrowest lesion in each segment and calculated as: ((reference diameter-minimal lumen diameter (MLD))/reference diameter)x100.

Secondary outcomes

  1. Change in mean carotid intima-media thickness (IMT)

    Time frame: From Baseline to Week 36 (9 months) and to Week 72 (18 months)

    Change from baseline in mean carotid IMT, as measured by duplex ultrasonography of common carotid arteries after 9 and 18 months.

  2. Numbers of Coronary segments Showing Regression

    Time frame: From baseline to End of study (Week 72)

    Clinically relevant regression or progression was defined as a change from baseline to follow up of ≥10% for percent diameter stenosis

  3. Number of Carotid Segments showing Regression

    Time frame: From Baseline to End of study (Week 72)

    Carotid IMT progression criterion for the 18 months of treatment was considered as growth rate of 0.02 mm (0.015 mm/yr). No changes or reduction in carotid IMT ≥ 0,02 mm served as criterion of stabilization and regression of carotid atherosclerosis, respectively.

  4. Change in total atheroma volume (TAV) from baseline to 18 months post-therapy

    Time frame: From Baseline to Week 72

    TAV at baseline - TAV at Week 72 assessed by intravascular ultrasound (IVUS) imaging of a targeted coronary artery

  5. Change in absolute volumes of plaque components

    Time frame: From Baseline to Week 72

    Mean change in absolute volumes of plaque components: fibrotic, fibrofatty, necrotic core or dense calcium, assessed by radiofrequency intravascular ultrasonographic (IVUS) imaging at baseline and 18 months post-therapy

  6. Change in relative amount of plaque components

    Time frame: From baseline to Week 72

    Mean change in relative amounts of plaque components: fibrotic, fibrofatty, necrotic core or dense calcium, assessed by radiofrequency intravascular ultrasonographic (IVUS) imaging at baseline and 18 months post-therapy

  7. Numbers of Coronary Plaques Showing Regression

    Time frame: From baseline to End of study (Week 72)

    Regression was defined as decrease in TAV for all anatomically comparable cross sectional areas of targeted coronary artery from baseline of ≥ 0,1 mm cubed

  8. Acute change in Lp(a) level

    Time frame: Once a week over 72 week period of active treatment

    Difference in Lp(a) concentration before and after specific Lp(a) apheresis procedure calculated as the mean of all measurements

  9. Change in quality of life (QOL)

    Time frame: from baseline to week 72

    To evaluate the impact of the specific Lp(a) removal therapy on the quality of life using Seattle Angina Questionnaire (SAQ) and Exercise stress test as compared with standard guideline-driven medical therapy of CHD patients

Other outcomes

  1. Total Cholesterol (TC) Serum Level

    Time frame: From Baseline to Week 4, 36, 72

    Mean changes in TC level over the 18-month study period

  2. Lipoprotein(a) (Lp(a)) serum levels

    Time frame: From Baseline to Week 4, 36, 72

    Mean changes in Lp(a) level over the 18-month study period

  3. Low-density lipoprotein cholesterol (LDL-C) serum Level

    Time frame: From Baseline to Week 4, 36, 72

    Mean changes in LDL-C level over the 18-month study period

  4. Change in corrected LDL-C (LDL-C corr) Serum level

    Time frame: From Baseline to Week 4, 36, 72

    Since all included patients had high Lp(a) levels, to avoid overestimation of LDL-C fraction estimated LDL-C levels were corrected for cholesterol derived from Lp(a).

    Corrected LDL-C (LDL-C corr) was calculated using Dahlen's modification of the Friedewald formula: LDL-C corr = TC - (HDL-C) - (TG / 2.2) - (0.3 x Lp(a) / 38.7).

    For values in mmol/L, Lp(a) in mg/dL

  5. Change in triglycerides (TG) serum Level

    Time frame: From Baseline to Week 4, 36, 72

    Mean changes in TG level over the 18-month study period

  6. Change in high-density lipoprotein cholesterol (HDL-C) serum level

    Time frame: From Baseline to Week 4, 36, 72

    Mean changes in HDL-C level over the 18-month study period

  7. Change in hemoglobin level

    Time frame: From Baseline to Week 4, 36, 72

  8. Change in creatinine level

    Time frame: From Baseline to Week 4, 36, 72

  9. Change in creatine kinase (CK) level

    Time frame: From Baseline to Week 4, 36, 72

  10. Change in alanine transaminase (ALT) level

    Time frame: From Baseline to Week 4, 36, 72

  11. Change in aspartate transaminase (AST) level

    Time frame: From Baseline to Week 4, 36, 72

Sponsors and collaborators

Lead sponsor

Russian Cardiology Research and Production Center

Other

Collaborators

  • Clinical Diagnostic Center MEDSI
  • Moscow State Government

Registry information

Official study title

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.

Acronym: LaRCA

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 8, 2014
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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