---
title: Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis
nct_id: NCT02133807
overall_status: COMPLETED
phase: PHASE3
sponsor: Russian Cardiology Research and Production Center
study_type: INTERVENTIONAL
primary_condition: Atherosclerosis
countries: Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02133807.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02133807"
ct_last_update_post_date: 2014-05-12
last_seen_at: "2026-05-12T06:32:56.214Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis

**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.

**NCT ID:** [NCT02133807](https://clinicaltrials.gov/study/NCT02133807)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Russian Cardiology Research and Production Center
- **Collaborators:** Clinical Diagnostic Center MEDSI, Moscow State Government
- **Conditions:** Atherosclerosis, Coronary Disease, Carotid Artery Diseases
- **Start Date:** 2009-09
- **Completion Date:** 2012-06
- **CT.gov Last Update:** 2014-05-12

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **Atorvastatin** (NO_INTERVENTION) — Standard medical therapy in accordance with the recommendations for secondary prevention of CHD

## Interventions

- **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

## Primary Outcomes

- **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

- **Change in mean carotid intima-media thickness (IMT)** _(time frame: From Baseline to Week 36 (9 months) and to Week 72 (18 months))_
- **Numbers of Coronary segments Showing Regression** _(time frame: From baseline to End of study (Week 72))_
- **Number of Carotid Segments showing Regression** _(time frame: From Baseline to End of study (Week 72))_
- **Change in total atheroma volume (TAV) from baseline to 18 months post-therapy** _(time frame: From Baseline to Week 72)_
- **Change in absolute volumes of plaque components** _(time frame: From Baseline to Week 72)_
- **Change in relative amount of plaque components** _(time frame: From baseline to Week 72)_
- **Numbers of Coronary Plaques Showing Regression** _(time frame: From baseline to End of study (Week 72))_
- **Acute change in Lp(a) level** _(time frame: Once a week over 72 week period of active treatment)_
- **Change in quality of life (QOL)** _(time frame: from baseline to week 72)_

## Locations (1)

- Russian Cardiology Research and Production Center, Moscow, Russia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.russian cardiology research and production center|moscow||russia` — added _(2026-05-12)_

---

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