Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-05 @ 6:57 PM
Study NCT ID:
NCT05541757
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2022-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban - Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anticoagulation level', 'timeFrame': '4 - 12 hours', 'description': 'anti-factor Xa'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '37209152', 'type': 'DERIVED', 'citation': 'Melek M, Ari H, Ari S, Cilgin MC, Yarar M, Huysal K, Agca FV, Bozat T. In vitro evaluation of anticoagulant therapy management when urgent percutaneous coronary intervention is required in rivaroxaban-treated patients. Naunyn Schmiedebergs Arch Pharmacol. 2023 Nov;396(11):3221-3232. doi: 10.1007/s00210-023-02533-2. Epub 2023 May 20.'}]}, 'descriptionModule': {'briefSummary': 'We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with persistent or permanent AF had been using rivaroxaban 20 mg daily for at least one month', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients using the direct oral factor Xa inhibitor rivaroxaban\n* Atrial fibrillation\n\nExclusion Criteria:\n\n* malignancy,\n* coagulopathy,\n* heart valve disease,\n* active infection,\n* chronic systemic or inflammatory disease,\n* recent ACS or elective PCI,\n* uncontrolled hypertension and diabetes,\n* cerebrovascular accident,\n* thyroid disorder,\n* left ventricular systolic dysfunction (ejection fraction \\<50%),\n* glomerular filtration rate \\<50 mL/min/1.73 m2,\n* underweight and overweight (\\<60 kg and \\>100 kg),\n* age \\>75 years,\n* hyperbilirubinemia and hypertriglyceridemia (\\>350 mg/dl).'}, 'identificationModule': {'nctId': 'NCT05541757', 'briefTitle': 'Rivaroxaban - Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Bursa Postgraduate Hospital'}, 'officialTitle': 'In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients', 'orgStudyIdInfo': {'id': 'BYİEAH4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'five healthy adults', 'interventionNames': ['Drug: In vitro heparin']}, {'label': 'Study group', 'description': 'Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban', 'interventionNames': ['Drug: In vitro heparin']}], 'interventions': [{'name': 'In vitro heparin', 'type': 'DRUG', 'description': 'In vitro heparin and in vitro LMWH', 'armGroupLabels': ['Study group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Postgraduate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Hasan ARI', 'investigatorAffiliation': 'Bursa Postgraduate Hospital'}}}}