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AtherosclerosisPhase 3LaRCANCT02133807

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

A Phase 3 study testing Specific Lp(a) apheresis in people with Atherosclerosis and Coronary Disease, run by Russian Cardiology Research and Production Center at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Specific Lp(a) apheresis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteRussia
Study dates
Sep 2009to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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 locations and contacts

1 site in 1 country.

Russia1 site

  • Russian Cardiology Research and Production Center

    Moscow, 121552

Other trials in Russia

About this study

Official 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.

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.

Read the 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.

Being tested
Specific Lp(a) apheresis
Keywords
Lipoprotein(a);, Lp(a) immunoadsorption;, Apheresis;, Coronary atherosclerosis;, Carotid Atherosclerosis;, Intima-media thickness;, Regression;, Quantitative Coronary Angiography;, Intravascular Ultrasound;, Virtual Histology;, Plaque;, Atorvastatin;
Medical subject headings
Atherosclerosis, Coronary Disease, Carotid Artery Diseases, Coronary Artery Disease, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specific Lp(a) apheresisProcedure or surgery

    Also called "Lp(a) Lipopak" immunoadsorption columns

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

Study groups in NCT02133807
Study groupRoleWhat they receive
Specific Lp(a) apheresis & AtorvastatinExperimentalSpecific 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.
Receives: Procedure: Specific Lp(a) apheresis
AtorvastatinNo interventionStandard medical therapy in accordance with the recommendations for secondary prevention of CHD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Baseline to End of Study (Week 72)

Secondary outcomes (9)

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

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

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

  2. Numbers of Coronary segments Showing Regression

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

    Measured: From baseline to End of study (Week 72)

  3. Number of Carotid Segments showing Regression

    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.

    Measured: From Baseline to End of study (Week 72)

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

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

    Measured: From Baseline to Week 72

  5. Change in absolute volumes of plaque components

    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

    Measured: From Baseline to Week 72

  6. Change in relative amount of plaque components

    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

    Measured: From baseline to Week 72

  7. Numbers of Coronary Plaques Showing Regression

    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

    Measured: From baseline to End of study (Week 72)

  8. Acute change in Lp(a) level

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

    Measured: Once a week over 72 week period of active treatment

  9. Change in quality of life (QOL)

    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

    Measured: from baseline to week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2014 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133807
Sponsor's protocol ID
01200953720
Acronym
LaRCA
Status last verified
May 2014
First submitted
6 May 2014
Last updated
12 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23357149

  • 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.

    PubMed 29096833

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

    PubMed 27213629

  • 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.

    PubMed 25936321

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Specific Lp(a) apheresis in people with Atherosclerosis and Coronary Disease, run by Russian Cardiology Research and Production Center at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percent Diameter Stenosis (time frame: From Baseline to End of Study (Week 72)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133807, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.

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