Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT05307718
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2022-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065427', 'term': 'Factor Xa Inhibitors'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D000991', 'term': 'Antithrombins'}, {'id': 'D015842', 'term': 'Serine Proteinase Inhibitors'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000925', 'term': 'Anticoagulants'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2022-03-23', 'studyFirstSubmitQcDate': '2022-03-23', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall project objective is to determine which pharmacogenes variants, together with clinical parameters, can be used as predictors of CV drug ADRs', 'timeFrame': '4.5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacogenetics; adverse drug reactions; statins; DOAK; platelet aggregation inhibitors'], 'conditions': ['Pharmacogenetics', 'Drug-Related Side Effects and Adverse Reactions', 'Cardiovascular Drugs']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://mef.unizg.hr/znanost/istrazivanje/web-stranice-projekata/projekt-hrzz-pgx-cardiodrug/', 'label': 'Project web site'}]}, 'descriptionModule': {'briefSummary': 'The research is planned as a prospective nested case-control study. The plan is to recruit about 1,200 consecutive subjects whose pharmacotherapy involves the drug(s) of interest within 4.5 years. The basic cohort - the subjects with the newly indicated indication for use: NOAC; platelet aggregation inhibitors from the P2Y12 receptor antagonist group; and HMG-CoA reductase inhibitors (statins); as monotherapy or without restriction with respect to any other concomitant pharmacotherapy. The ADRs will be analysed by CR by: age, gender, expectancy, severity, association, type (mechanism of event), and outcome, according to the classification of organ systems as well as association with the phenotype. Criteria for bleeding associated with the use of anticoagulant and antiplatelet therapy have been defined; as well as the myotoxicity and hepatotoxicity associated with statin therapy. Samples will be tested for biochemical, haematological, coagulation standard parameters and pharmacogenetic analyses of relevant genes depending on the used therapy. Pharmacogenetic analysis will be performed to genotype the polymorphisms of relevant pharmacogenes: Biological samples and clinical data will be anonymized plus all records of ADRs and other clinical variables will be protected. Possible drug-drug and drug-drug-gene interactions will be evaluated using the Clinical Decision Support System (CDSS) of Lexicomp, PharmGKB, the Flockhart Table, and other systems including panel consensus methods to determine the likelihood of an ADR being associated with drug interactions, and determine whether drug interactions contributed to the occurrence of ADRs to administered CV pharmacotherapy in subjects with variant pharmacogenes of interest (drug-drug-gene interaction). The overall project objective is to determine which pharmacogenes variants, together with clinical parameters, can be used as predictors of CV drug ADRs and are good candidates for inclusion in the clinical diagnostic panel for pre-emptive PGx testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The primary cohort is represented by subjects who have a new indication for the administration of a) new oral anticoagulants (NOAC); b) platelet aggregation inhibitors from the P2Y12 receptor antagonist group (clopidogrel, prasugrel, ticagrelor); c) an HMG-CoA reductase inhibitor (statins); for the purpose of treatment or prophylaxis for at least 3 months; as monotherapy or without restriction with respect to any other concomitant pharmacological therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\na) age 18 years or older; b) a new indication for the administration of any of the medicinal products of primary interest (NOAC, clopidogrel, prasugrel, ticagrelor, statins) for which at least a 3-month administration is predicted; c) signed informed consent (for repeated evaluations and donation of blood samples for genetic and eventual pharmacokinetic analysis).\n\nExclusion Criteria:\n\nthe existence of contraindications to the medicines of primary interest.'}, 'identificationModule': {'nctId': 'NCT05307718', 'briefTitle': 'Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Hospital Centre Zagreb'}, 'officialTitle': 'Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction', 'orgStudyIdInfo': {'id': 'UIP-2020-02-8189'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The basic cohort', 'description': 'The subjects with the newly indicated indication for use: NOAC; platelet aggregation inhibitors from the P2Y12 receptor antagonist group; and HMG-CoA reductase inhibitors (statins', 'interventionNames': ['Drug: Oral Anticoagulant, Direct-Acting']}, {'label': 'Cases', 'description': 'Cases will be subjects who have observed ADRs during follow-up: bleeding that meets the criteria of "major" or "non-major, clinically relevant bleeding (for anticoagulants and platelet aggregation inhibitors); muscle or liver lesions (for statins); any other serious ADR.', 'interventionNames': ['Drug: Oral Anticoagulant, Direct-Acting']}, {'label': 'Controls', 'description': 'Controls will be subjects in whom no ADRs were observed during the study', 'interventionNames': ['Drug: Oral Anticoagulant, Direct-Acting']}], 'interventions': [{'name': 'Oral Anticoagulant, Direct-Acting', 'type': 'DRUG', 'otherNames': ['HMG-CoA reductase inhibitors', 'platelet aggregation inhibitors from the P2Y12 receptor antagonist group'], 'description': 'Newly indicated indication for use: DOAC; platelet aggregation inhibitors from the P2Y12 receptor antagonist group; and HMG-CoA reductase inhibitors (statins); as monotherapy or without restriction with respect to any other concomitant pharmacotherapy. Subjects will be followed up during regular visits.', 'armGroupLabels': ['Cases', 'Controls', 'The basic cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Tamara Bozina, PhD', 'role': 'CONTACT', 'email': 'tamara.bozina@mef.hr', 'phone': '+385 1 4566 777'}, {'name': 'Livija Šimičević, PhD', 'role': 'CONTACT', 'email': 'lsimicev@kbc-zagreb.hr', 'phone': '+385 1 2388 888'}], 'facility': 'UHC Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'centralContacts': [{'name': 'Tamara Bozina, PhD', 'role': 'CONTACT', 'email': 'tamara.bozina@mef.hr', 'phone': '+385 1 45 66 777'}, {'name': 'Livija Šimičević, PhD', 'role': 'CONTACT', 'email': 'lsimicev@kbc-zagreb.hr', 'phone': '+385 1 2388 888'}], 'overallOfficials': [{'name': 'Tamara Bozina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zagreb, Schooll of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Hospital Centre Zagreb', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zagreb School of Medicine', 'class': 'UNKNOWN'}, {'name': 'Croatian Science Foundation', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Livija Simicevic', 'investigatorFullName': 'Livija Šimičević', 'investigatorAffiliation': 'Clinical Hospital Centre Zagreb'}}}}