NCT02133807

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

2.5 years

First QC Date

May 6, 2014

Last Update Submit

May 9, 2014

Conditions

AtherosclerosisCoronary DiseaseCarotid Artery Diseases

Keywords

Lipoprotein(a);Lp(a) immunoadsorption;Apheresis;Coronary atherosclerosis;Carotid Atherosclerosis;Intima-media thickness;Regression;Quantitative Coronary Angiography;Intravascular Ultrasound;Virtual Histology;Plaque;Atorvastatin;

Outcome Measures

Primary Outcomes (1)

  • Change in Percent Diameter Stenosis

    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.

    From Baseline to End of Study (Week 72)

Secondary Outcomes (9)

  • Change in mean carotid intima-media thickness (IMT)

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

  • Numbers of Coronary segments Showing Regression

    From baseline to End of study (Week 72)

  • Number of Carotid Segments showing Regression

    From Baseline to End of study (Week 72)

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

    From Baseline to Week 72

  • Change in absolute volumes of plaque components

    From Baseline to Week 72

  • +4 more secondary outcomes

Other Outcomes (11)

  • Total Cholesterol (TC) Serum Level

    From Baseline to Week 4, 36, 72

  • Lipoprotein(a) (Lp(a)) serum levels

    From Baseline to Week 4, 36, 72

  • Low-density lipoprotein cholesterol (LDL-C) serum Level

    From Baseline to Week 4, 36, 72

  • +8 more other outcomes

Study Arms (2)

Specific Lp(a) apheresis & Atorvastatin

EXPERIMENTAL

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.

Procedure: Specific Lp(a) apheresis

Atorvastatin

NO INTERVENTION

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

Interventions

Specific Lp(a) apheresisPROCEDURE

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

Also known as: "Lp(a) Lipopak" immunoadsorption columns
Specific Lp(a) apheresis & Atorvastatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Russian Cardiology Research and Production Center

Moscow, 121552, Russia

Location

Related Publications (4)

  • Safarova MS, Ezhov MV, Afanasieva OI, Matchin YG, Atanesyan RV, Adamova IY, Utkina EA, Konovalov GA, Pokrovsky SN. Effect of specific lipoprotein(a) apheresis on coronary atherosclerosis regression assessed by quantitative coronary angiography. Atheroscler Suppl. 2013 Jan;14(1):93-9. doi: 10.1016/j.atherosclerosissup.2012.10.015.

    PMID: 23357149RESULT

  • Pokrovsky SN, Afanasieva OI, Safarova MS, Balakhonova TV, Matchin YG, Adamova IYU, Konovalov GA, Ezhov MV. Specific Lp(a) apheresis: A tool to prove lipoprotein(a) atherogenicity. Atheroscler Suppl. 2017 Nov;30:166-173. doi: 10.1016/j.atherosclerosissup.2017.05.004. Epub 2017 May 31.

    PMID: 29096833DERIVED

  • Pokrovsky SN, Afanasieva OI, Ezhov MV. Lipoprotein(a) apheresis. Curr Opin Lipidol. 2016 Aug;27(4):351-8. doi: 10.1097/MOL.0000000000000319.

    PMID: 27213629DERIVED

  • Ezhov MV, Safarova MS, Afanasieva OI, Pogorelova OA, Tripoten MI, Adamova IY, Konovalov GA, Balakhonova TV, Pokrovsky SN. Specific Lipoprotein(a) apheresis attenuates progression of carotid intima-media thickness in coronary heart disease patients with high lipoprotein(a) levels. Atheroscler Suppl. 2015 May;18:163-9. doi: 10.1016/j.atherosclerosissup.2015.02.025.

    PMID: 25936321DERIVED

MeSH Terms

Conditions

AtherosclerosisCoronary DiseaseCarotid Artery DiseasesCoronary Artery DiseasePlaque, Amyloid

Interventions

Blood Component RemovalApolipoproteins A

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsApolipoproteinsLipoproteinsLipidsApoproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Sergei Pokrovsky, PhD, DSc

    Russian Cardiology Research and Production Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Laboratory of Atherosclerosis

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

September 1, 2009

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

RU(1)