An observational study in Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, sponsored by Technische Universität Dresden. Status unknown at 12 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Technische Universität Dresden · Observational
This multicenter multinational prospective two-arm matched-pair observational study aims to establish a prospective comparison of active lipoprotein apheresis treatment approved and conducted according to German guidelines for the indication of elevated Lp(a) versus a maximum tolerated lipid-lowering therapy as standard care. Due to the prospective character and the inclusion of a control arm, this will be the first clinical study that can confirm the relevance of the established approach to use lipoprotein apheresis in those subjects and its effects to reduce the individual cardiovascular risk. The optimized management of subjects in the control group (not receiving lipoprotein apheresis) will also help to clarify the controversial issue, to which extent intensive medical care per se can influence the occurence of subsequent cardiovascular events. Primary objective of the trial is to evaluate the clinical benefit of Lp(a) reduction using lipoprotein apheresis on myocardial infarction, PCI, CABG, fatal and non- fatal stroke, transient ischemic attack, interventional or surgical revascularization of peripheral arteries and death from cardiovascular disease. The primary objective of this study evaluates the clinical benefit of weekly lipoprotein apheresis in subjects with progressive cardiovascular disease, as accepted by the German Federal Joint Committee as indication for subjects with elevated Lp(a). Comparator will be matched subjects under maximum tolerated lipid lowering therapy without access to lipoprotein apheresis treatment. The clinical benefit will be defined as the reduction of the composite endpoint of major adverse cardiovascular events (MACE), defined as either myocardial infarction, PCI, CABG, fatal and non-fatal stroke, transient ischemic attack or death from cardiovascular disease over a period of at least 2 years after completion of visit 1b and until at least 60 events of the primary end-point occurred in group B. If the number of at least 60 documented primary endpoint events within 2 years of the completion of enrolment did not occur, the study will continue until this number of primary endpoint events has accumulated.
283 studies on the registry are indexed under Hyperlipoproteinemias; 21 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 250 across 38 observational studies indexed under Hyperlipoproteinemias.
Browse Hyperlipoproteinemias studies →Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All participants have to be 18 years or older and need to be intellectually capable to understand and follow the study protocol. All subjects have to present with progressive cardiovascular disease and need to fulfill the criteria fixed in the recommendations by the German Joint Federal Committee (in German: "Gemeinsamer Bundesausschuss"; see section 1.2). In addition, a TEC has to verify presence of the treatment indication and will be blinded with respect to subject's group assignment. Apheresis subjects (group A) will be included in chronological order, since this will most likely reflect the natural distribution of disease in the general population. Control subjects (group B) will then be matched to the lipoprotein apheresis subjects entering the study.
Established cardiovascular disease with disease progression indicated by one major cardiovascular event, which might be either
(with or without subsequent cardiovascular events/interventions) despite adequately controlled cardiovascular risk factors* occuring within the last 2 years prior to enrolment
(*Hypertension, Diabetes, tobacco consumption, LDL Cholesterol)
Exclusion Criteria:
Established cardiovascular disease with disease progression indicated by one major cardiovascular event. With or without subsequent cardiovascular events/interventions, despite adequately controlled cardiovascular risk factors occuring within the last 2 years prior to enrolment. Corrected Low-density lipoprotein cholesterol \< 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment. Additional lipoprotein apheresis is established following enrolment using the following established systems: Dextran-sulfate adsorption (DSA) from plasma and whole blood, Heparin-induced LDL precipitation apheresis (HELP®), Polyacrylate adsorption from whole blood and simple DFPP (DALI® and Monet®), ApoB100-immunoadsorption (TheraSorbLDL®, Temperature-optimized double filtration plasmapheresis (DFPP).
Established cardiovascular disease with disease progression indicated by one major cardiovascular event. With or without subsequent cardiovascular events/interventions, despite adequately controlled cardiovascular risk factors occuring within the last 2 years prior to enrolment. Corrected Low-density lipoprotein cholesterol \< 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment. The control group will not undergo a sham apheresis procedure. It is an open trial.
The primary end-point is an at least 10 % reduction of the proportion of events
The primary end-point is an at least 10 % reduction of the proportion of events regarding the composite end-point consisting either of myocardial infarction, PCI, CABG, fatal and non-fatal stroke, transient ischemic attack, interventional or surgical revascularization of peripheral arteries or death from cardiovascular disease (or any combination of these) at the final visit.
Time frame: 2 years of follow-up
An at least 10 % reduction of the proportion of events
An at least 10 % reduction of the proportion of events regarding the composite endpoint of cardiovascular death, major coronary event, cerebrovascular accidents and stroke.
Time frame: 2 years of follow-up
An at least 10 % reduction of the proportion of events
An at least 10 % reduction of the proportion of events regarding the composite endpoint of cardiovascular death, major coronary events and all cerebrovascular events.
Time frame: 2 years of follow-up
An at least 10 % reduction of the proportion of events regarding the composite Secondary endpoints of the Trial
An at least 10 % reduction of the proportion of events regarding the composite endpoint of CV death, non-fatal MI, documented unstable angina that requires admission into a hospital, all revascularization (including both coronary and non-coronary) occurring at least 30 days after the MACE event, the rate of in-stent restenosis and non-fatal stroke.
Time frame: 2 years of follow-up
Reduction of individual endpoints
Reduction of individual endpoints at the final visit, reported as % reduction of the number of cumulated and individual events * death from any cause, * CHD death, * CV death, * MI, * documented unstable angina that requires admission into a hospi-tal, * all coronary revascularization occurring at least 30 days after a prior MACE event: * either PCI or * CABG * all revascularization (including both coronary and non-coronary) occurring at least 30 days after a prior MACE event, * in-stent restenosis rate, * stroke, * transient ischemic attack, * Percentage of subjects achieving a mean reduction of Lp(a) of 60% or more * Mean reduction of Lp(a) * Percentage of subjects achieving mean LDL-C reduction of 60 % or more * Number of apheresis related side effects * Quality of life
Time frame: 2 years of follow-up
Plan to share: Undecided
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Technische Universität Dresden