Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT03315650
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2017-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1632}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2017-10-10', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI', 'timeFrame': '18 months', 'description': 'Real-life data on the prescription of antithrombotic medication for patients with atrial fibrillation after PCI'}], 'secondaryOutcomes': [{'measure': 'Evaluation of antithrombotic medication during long-term follow-up', 'timeFrame': '14 months', 'description': 'Patients receiving Rivaroxaban after index PCI are asked for their further antithrombotic medication in two telephone interviews (3 months and 14 months after index PCI)'}, {'measure': 'Adverse Events during baseline and follow-up', 'timeFrame': '32 months', 'description': 'Documentation of Adverse Events during baseline hospital stay (by treating physician) and during long-term follow-up (patient-reported)'}, {'measure': 'Treatment adherence of patients', 'timeFrame': '14 months', 'description': 'Patient-reported information on their adherence to the antithrombotic treatment strategy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-valvular AF', 'ACS', 'PCI', 'NOAC', 'Rivaroxaban'], 'conditions': ['Non-valvular Atrial Fibrillation', 'Acute Coronary Syndrome', 'Percutaneous Coronary Intervention', 'Antithrombotic Therapy']}, 'referencesModule': {'references': [{'pmid': '36493580', 'type': 'DERIVED', 'citation': 'Zeymer U, Toelg R, Wienbergen H, Hobbach HP, Cuneo A, Bekeredjian R, Ritter O, Hailer B, Hertting K, Hennersdorf M, Scholtz W, Lanzer P, Mudra H, Schwefer M, Schwimmbeck PL, Liebetrau C, Thiele H, Claas C, Riemer T, Zahn R. Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice. Am J Cardiol. 2023 Feb 15;189:31-37. doi: 10.1016/j.amjcard.2022.11.009. Epub 2022 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the antithrombotic therapy in patients suffering from atrial fibrillation after stent implantation in Germany. Patients prescribed with the novel oral anticoagulant Rivaroxaban will be followed up over 14 months for their adherence to the medication schedule and for complications that occurred after index PCI.', 'detailedDescription': 'Patients suffering from non-valvular atrial fibrillation and presenting with an acute coronary syndrome require special attention with regard to antithrombotic therapy. Current guidelines recommend use of oral anticoagulation for almost all of these patients, the optimal antithrombotic strategy, however, has still to be defined. As with the use of any antithrombotic drug, clinicians need to balance the risks of ischemic stroke and thromboembolism, recurrent cardiac ischemia and/or stent thrombosis, and bleeding and haemorrhagic stroke.\n\nA recently published randomized clinical trial (PIONEER AF) compared the combination of a novel oral anticoagulant (NOAC; Rivaroxaban) plus dual anti-platelet therapy (DAPT) with standard therapy consisting of vitamine K inhibitor plus DAPT. Patients treated with Rivaroxaban showed less incidence of bleedings, whereas ischemic complications, death or stroke were equal in the groups compared.\n\nThe RIVA-PCI Registry aims at providing an overview of the current antithrombotic treatment regimen in Germany in real life. Moreover, for patients receiving Rivaroxaban as part of their medication follow-up data with regard to their adherence to antithrombotic medication as well as complications over an interval of 14 months after index procedure will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive, unselected recruitment of patients fulfilling the eligibility criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years and capable of giving written informed consent\n* Known or newly diagnosed non-valvular atrial fibrillation\n* PCI with stent implantation during index hospital stay\n* Written informed consent for participation in observational study (incl. telephone follow-up)\n* Not simultaneously participating in any randomized trial\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03315650', 'acronym': 'RIVA-PCI', 'briefTitle': 'Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI', 'organization': {'class': 'OTHER', 'fullName': 'IHF GmbH - Institut für Herzinfarktforschung'}, 'officialTitle': 'RIVA-PCI Registry - Prospective Registry of Rivaroxaban in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'RIVA-PCI'}}, 'contactsLocationsModule': {'locations': [{'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Segeberger Kliniken', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'zip': '06749', 'city': 'Bitterfeld-Wolfen', 'country': 'Germany', 'facility': 'Gesundheitszentrum Bitterfeld-Wolfen', 'geoPoint': {'lat': 51.62355, 'lon': 12.32395}}, {'zip': '28277', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Links der Weser', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '21244', 'city': 'Buchholz', 'country': 'Germany', 'facility': 'Krankenhaus Buchholz', 'geoPoint': {'lat': 53.01126, 'lon': 9.56119}}, {'zip': '96450', 'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '74078', 'city': 'Heilbronn', 'country': 'Germany', 'facility': 'SLK-Kliniken Heilbronn', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Städtisches Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Universitätsklinikum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum der Universität München , Campus Großhadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '57076', 'city': 'Siegen', 'country': 'Germany', 'facility': 'Kreisklinikum Siegen', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '78052', 'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': 'Schwarzwald-Baar Klinikum', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}], 'overallOfficials': [{'name': 'Uwe Zeymer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut für Herzinfarktforschung (Institute for Cardiac Research)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'An intermediate report summarizing the baseline data will be provided to Bayer (financial support).\n\nA final report summarizing baseline and follow-up data will be provided to ethical committees in Germany, to governmental authority, and to Bayer.\n\nParticipating clinics will receive benchmarking reports (comparison of their own data with those of all other sites).\n\nData will be made accessible to participating investigators for publication in journals and on conferences.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IHF GmbH - Institut für Herzinfarktforschung', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}