Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-01 @ 5:55 AM
Study NCT ID:
NCT01064934
Status:
WITHDRAWN
Last Update Posted:
2015-06-04
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint, defined as first occurrence of one of the following: myocardial infarction, interventional therapeutic procedure, CABG, cerebrovascular accident, hospitalization due to ACS, periph. art. revasc., death from cardiovascular cause', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Components of the primary endpoint considered individually', 'timeFrame': '5 years'}, {'measure': 'Death from any cause', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary heart disease', 'cerebrovascular disease', 'peripheral arterial disease', 'atherosclerosis', 'hyperlipoproteinemia'], 'conditions': ['Hyperlipoproteinemia(a)', 'Progressive Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Lipoprotein(a) \\[Lp(a)\\] is an independent risk factor for cardiovascular disease. Non-medical treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma concentrations. Drug therapy has only limited influence, e.g. treatment with niacin. Statins are usually without effect. Lipid apheresis is the only treatment known to lower elevated Lp(a) levels in a relevant way. In patients with pronounced elevation of Lp(a) and normal LDL cholesterol levels, who suffer from progressive cardiovascular disease, the treatment with lipid apheresis seems to be a last-resort treatment option. The current trial will evaluate the effectiveness of lipid apheresis on cardioavascular endpoints.', 'detailedDescription': 'Lipoprotein(a) \\[Lp(a)\\] is an independent risk factor for cardiovascular disease. Non-medical treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma concentrations. Drug therapy has only limited influence, e.g. treatment with niacin. Statins are usually without effect. Lipid apheresis is the only treatment known to lower elevated Lp(a) levels in a relevant way. In patients with pronounced elevation of Lp(a) and normal LDL cholesterol levels, who suffer from progressive cardiovascular disease, the treatment with lipid apheresis seems to be a last-resort treatment option. The current trial will evaluate the effectiveness of lipid apheresis on cardioavascular endpoints. The trial is a randomized multicenter trial in Germany. Patients will be randomized to the apheresis group or to the control group. All patients will receive maximal risk minimizing therapies. The apheresis group will receive in addition weekly lipid apheresis. The principal outcome parameter is a composite endpoint of non-fatal myocardial infarction, interventional therapeutic procedure (PCI, stenting), coronary bypass surgery (CABG), non-fatal ischemic cerebrovascular accident, hospitalization due to acute coronary syndrome (ACS), critical limb ischemia, peripheral arterial revascularization procedure; amputation, death from cardiovascular cause.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years of age\n* Male or female\n* Written informed consent\n* Lipoprotein(a) \\>=60 mg/dL\n* Low-density lipoprotein cholesterol \\<130 mg/dL\n* Progressive cardiovascular disease\n* Positive recommendation by the Inclusion Committee\n\nExclusion Criteria:\n\n* Current participation in a lipid apheresis program\n* Previous participation in a lipid apheresis program\n* Low-density lipoprotein cholesterol \\>=130 mg/dL under maximally tolerated (or necessary) drug treatment\n* Triglyceride concentrations \\>=450 mg/dL\n* Known homozygous familial hypercholesterolemia\n* Known type III hyperlipoproteinemia\n* Pregnancy, breast feeding\n* History of malignant disease (with the exception of non-melanoma carcinomas of the skin and carcinoma in situ of the cervix)\n* Planned major surgical procedures in the next 3 months\n* Current participation in another interventional trial\n* Previous randomization in the current trial (applies only for the RCT)'}, 'identificationModule': {'nctId': 'NCT01064934', 'acronym': 'ELAILa', 'briefTitle': 'Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Randomized Controlled Trial of Efficacy and Safety of Lipid Apheresis for the Prevention of Cardiovasc. Events in Patients With Progr. Cardiovasc. Disease, Lp(a)℠60 mg/dl and LDL-C <130 mg/dl on Maximally Tolerated Lipid-lowering Therapy', 'orgStudyIdInfo': {'id': 'ELAILa-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipid apheresis', 'description': 'Lipid apheresis', 'interventionNames': ['Procedure: Lipid apheresis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Standard care', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Lipid apheresis', 'type': 'PROCEDURE', 'description': 'Weekly lipid apheresis procedure for lipoprotein(a) lowering', 'armGroupLabels': ['Lipid apheresis']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Standard care for maximum cardiovascular risk reduction (behavioural, exercise, nutrition, drugs, etc.)', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Lipidambulanz, InterdisziplinÀres Stoffwechsel-Centrum, CVK, Charite', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Heiner K. Berthold, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}, {'name': 'Elisabeth Steinhagen-Thiessen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Heiner K. Berthold, Professor, and Elisabeth Steinhagen-Thiessen, Professor', 'oldOrganization': 'Charite University Medicine Berlin'}}}}