Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis (NCT02133807) | Clinical Trial Compass
CompletedPhase 3
Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis
Russia32 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Percent Diameter Stenosis
Timeframe: From Baseline to End of Study (Week 72)
Trial details
NCT IDNCT02133807
SponsorRussian Cardiology Research and Production Center