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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change in Percent Diameter Stenosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
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)(From Baseline to Week 36 (9 months) and to Week 72 (18 months))
- Change in relative amount of plaque components(From baseline to Week 72)
- Numbers of Coronary segments Showing Regression(From baseline to End of study (Week 72))
- Acute change in Lp(a) level(Once a week over 72 week period of active treatment)
- 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)
- Numbers of Coronary Plaques Showing Regression(From baseline to End of study (Week 72))
- Change in quality of life (QOL)(from baseline to week 72)
Investigators
Professor Sergei Pokrovsky, PhD, DSc
Chair of the Laboratory of Atherosclerosis
Russian Cardiology Research and Production Center