Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis (LaRCA)
Atherosclerosis, Coronary Disease, Carotid Artery Diseases
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Lipoprotein(a);, Lp(a) immunoadsorption;, Apheresis;, Coronary atherosclerosis;, Carotid Atherosclerosis;, Intima-media thickness;, Regression;, Quantitative Coronary Angiography;, Intravascular Ultrasound;, Virtual Histology;, Plaque;, Atorvastatin;
Eligibility Criteria
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
Sites / Locations
- Russian Cardiology Research and Production Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Specific Lp(a) apheresis & Atorvastatin
Atorvastatin
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.
Standard medical therapy in accordance with the recommendations for secondary prevention of CHD