Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-13 @ 12:42 PM
Study NCT ID:
NCT03110432
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2017-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D000090542', 'term': 'Homozygous Familial Hypercholesterolemia'}, {'id': 'D006950', 'term': 'Hyperlipidemia, Familial Combined'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075010', 'term': 'erucylphosphocholine'}, {'id': 'C577155', 'term': 'evolocumab'}, {'id': 'C571059', 'term': 'alirocumab'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D009525', 'term': 'Niacin'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D000069472', 'term': 'Colesevelam Hydrochloride'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000499', 'term': 'Allylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000498', 'term': 'Allyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1695}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in quality of life', 'timeFrame': 'up to 3 years', 'description': 'by EuroQol 5 dimensions'}], 'primaryOutcomes': [{'measure': 'LDL cholesterol goal achievement', 'timeFrame': '3 years', 'description': '\\< 70 mg/dl'}], 'secondaryOutcomes': [{'measure': 'LDL cholesterol reduction', 'timeFrame': 'up top 3 years', 'description': 'Compared to baseline'}, {'measure': 'Number of treatment changes', 'timeFrame': 'up to 3 years', 'description': 'During the follow-up period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular', 'LDL Cholesterol', 'Drug utlisation', 'high risk', 'secondary prevention', 'PCSK9 inhibition'], 'conditions': ['Dyslipoproteinemias', 'Hypercholesterolemia, Familial', 'Familial Hypercholesterolemia - Homozygous', 'Familial Combined Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '40270128', 'type': 'BACKGROUND', 'citation': 'Parhofer KG, Pittrow D, Birkenfeld AL, Fraass U, Hohenstein B, Siegert C, Klotsche J, Steinhagen-Thiessen E, Dexl S, Schettler VJJ, Laufs U. Determinants of lipid lowering therapy intensification in very high risk patients with dyslipidaemia eligible for PCSK9 monoclonal antibodies: 1-year outcomes of the PERI-DYS study. Acta Cardiol. 2025 Jul;80(5):475-486. doi: 10.1080/00015385.2025.2490381. Epub 2025 Apr 24.'}, {'pmid': '36178485', 'type': 'BACKGROUND', 'citation': 'Laufs U, Birkenfeld AL, Fraass U, Hohenstein B, Siegert C, Klotsche J, Steinhagen-Thiessen E, Pittrow D, Dexl S, Salmen S, Schettler VJJ, Parhofer KG; Collaborators in the PERI-DYS Study. Novel Insights into the Management of Patients with Very High Cardiovascular Risk Eligible for PCSK9 Inhibitor Treatment: Baseline Findings from the PERI-DYS Study. Cardiovasc Drugs Ther. 2024 Feb;38(1):119-129. doi: 10.1007/s10557-022-07386-0. Epub 2022 Sep 30.'}, {'pmid': '40760109', 'type': 'DERIVED', 'citation': 'Parhofer KG, Pittrow D, Birkenfeld AL, Fraass U, Hohenstein B, Siegert C, Klotsche J, Steinhagen-Thiessen E, Dexl S, Schettler VJJ, Laufs U. Treatment persistence, lipid lowering, and 3-year clinical outcomes in patients at very high cardiovascular risk on PCSK9 monoclonal antibodies. Clin Res Cardiol. 2025 Aug 4. doi: 10.1007/s00392-025-02719-z. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective German registry for patients with dyslipidemia with very high cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are treated by office-based cardiologists or in lipid ambulances.', 'detailedDescription': 'The study is purely observational, and will document data from the patient charts only. Treatment of patients will not be changed by this study, and all clinical decisions (including on frequency of visits) will be upon the discretion of the physician. No blood samples must be taken solely for the purpose of the study.\n\nThe registry will include two types of centers: 1) office-based cardiologists and 2) specialized lipid ambulances (outpatient departments).\n\nData on patient disease and treatment history will be collected a first documentation (retrospectively).\n\nThe documentation time is 3 years per patient. After the baseline visit, patients are followed-up every 6 ± 2months (last visit at month 36). This interval is considered narrow enough not to miss important events (safety reporting, cardiovascular events, hospitalizations).\n\nPatients with stable (maintenance) lipid-lowering therapy (including those with existing PCSK9i therapy) or those with any therapy changes (including newly initiated PCSK9i treatment) will be documented in this study. Compared to the former group with stable drug treatment, the latter group will likely have major LDL-C changes during the first few weeks, which will be accounted for by (retrospective) monthly documentation in the first 3 months (data will be documented at the 6-month visit.\n\nThe documentation periods will be substantially longer than in the controlled studies of the PCSK9i (endpoints were as early as 3 months), and thus will provide much-needed information about the long-term effects on LDL-C and other lipid parameters, safety, and drug retention rates. Longer follow-up periods would likely be compromised by high rates of (administrative) discontinuation rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with dyslipidemia and very high cardiovascular risk ("highest risk patients" according to G-BA stipulation for PCSK9i use)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or\n\n * with confirmed familial, heterozygous hypercholesterolemia under consideration of the total familial risk, or\n * with heterozygous familial or non- familial hypercholesterolemia or mixed dyslipidemia with\n\n * therapy refractory course\n * maximal dietary and pharmaceutical lipid lowering therapy - in any case documented over a 12-month period\n * unsatisfactorily lowered LDL-C value (and thus with an indication for LDL apheresis)\n * confirmed vascular disease\n * other risk factors for cardiovascular events\n\nExclusion Criteria:\n\n* Concurrent participation of the patient in a clinical randomised study.'}, 'identificationModule': {'nctId': 'NCT03110432', 'acronym': 'PERI-DYS', 'briefTitle': 'Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry', 'organization': {'class': 'OTHER', 'fullName': 'GWT-TUD GmbH'}, 'officialTitle': 'Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry', 'orgStudyIdInfo': {'id': 'PERI-DYS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard lipid lowering therapy', 'description': 'Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids (and any combinations of these agents)', 'interventionNames': ['Drug: Standard lipid lowering therapy']}, {'label': 'PCSK9 Inhibitor [EPC]', 'description': 'Evolocumab or alirocumab.', 'interventionNames': ['Drug: PCSK9 Inhibitor [EPC]']}], 'interventions': [{'name': 'PCSK9 Inhibitor [EPC]', 'type': 'DRUG', 'otherNames': ['Repatha, Praluent'], 'description': 'drug use according to the respective product labelling', 'armGroupLabels': ['PCSK9 Inhibitor [EPC]']}, {'name': 'Standard lipid lowering therapy', 'type': 'DRUG', 'otherNames': ['Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids'], 'description': 'drug use according to the respective product labelling', 'armGroupLabels': ['Standard lipid lowering therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leipzig', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': 'Nephrologisches Zentrum', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}], 'overallOfficials': [{'name': 'David Pittrow, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GWT-TUD GmbH, Germany'}, {'name': 'Andreas Birkenfeld, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum Tuebingen, Germany'}, {'name': 'Bernd Hohenstein, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrologisches Zentrum Villingen-Schwenningen, Germany'}, {'name': 'Ulrich Laufs, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinik für Innere Medizin III, Universität des Saarlandes, Germany'}, {'name': 'Volker JJ Schettler, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrologisches Zentrum Göttingen GbR, Germany'}, {'name': 'Elisabeth Steinhagen-Thiessen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lipid Clinic, Charité Universitaetsmedizin, Berlin, Germany'}, {'name': 'Klaus G Parhofer, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ludwig Maximilian University, Medizinische Klinik und Poliklinik IV, Muenchen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GWT-TUD GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}