Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 6:26 PM
Study NCT ID:
NCT05750758
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2023-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban Combined With DAPT Versus DAPT Alone After Drug-coated Balloon Angioplasty
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late lumen loss ( LLL)', 'timeFrame': '6 months', 'description': 'Evaluation of postoperative target vessel LLL at follow-up using QCA'}], 'secondaryOutcomes': [{'measure': 'Vascular dissection healing', 'timeFrame': '6 months', 'description': 'Re-use CAG to evaluate the vascular reexamination of the original dissection'}, {'measure': 'Minimum lumen area', 'timeFrame': '6 months', 'description': 'using CAG'}, {'measure': 'Cardiovascular death', 'timeFrame': '6 months', 'description': 'All deaths are counted as cardiovascular deaths unless there is a clear determination of other causes'}, {'measure': 'Target vessel myocardial infarction', 'timeFrame': '6 months', 'description': 'CAG confirms'}, {'measure': 'Clinical-driven revascularization of target lesions', 'timeFrame': '6 months', 'description': 'Clinical-driven revascularization of target lesions'}, {'measure': 'Bleeding events defined by BARC', 'timeFrame': '6 months', 'description': 'Bleeding events defined by BARC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The target population of this interventional study was ACS patients with drug-coated balloons. The main discussion : 1.1 months of rivaroxaban combined with dual antiplatelet therapy compared with dual antiplatelet therapy alone, late lumen loss at 6 months. 2. To determine the safety of the regimen with bleeding events as the end point. Subjects were randomly assigned to two groups, one receiving routine DAPT for six months and one receiving DAPT plus one month of rivaroxaban 2.5 mg bid', 'detailedDescription': 'Drug-coated balloon ( DCB ) is to apply anti-intimal hyperplasia drugs to the surface of the balloon. When the balloon reaches the diseased blood vessel and is stretched and expanded, it contacts the intima of the blood vessel wall. By tearing the intima of the blood vessel and pressing, the transfer drug is quickly released to the intima of the blood vessel, thereby preventing restenosis after vascular intervention. Pretreatment is a key step in the use of drug balloons in situ macroangiopathy. At present, it is required that the residual stenosis of the lesion during pretreatment is ≤ 30 %, and there is no distal blood flow restrictive dissection and hematoma. The relationship between dissection hematoma and residual stenosis is difficult to deal with. Some small dissections are beneficial to the absorption of DCB anti-proliferative drugs by the vascular wall. The larger dissection may cause the thrombus to persist in the vascular wall, resulting in late lumen loss after organization. Rivaroxaban is a new oral anticoagulant, which is gradually used in the treatment of coronary heart disease. At present, there is no clinical study on the prognosis of vascular dissection in DCB. Based on the above research background, we designed the following trial, aimed to study in ACS population, vascular lumen access + hemorrhagic events as the end point, try to clear 1 month rivaroxaban combined with dual antiplatelet therapy compared with single dual antiplatelet therapy effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ACS patients who meet the indications of percutaneous coronary intervention\n* The reference diameter of the target vessel was ≥2.75mm\n* Target lesions were treated with a drug-coated balloon catheter (DCB) for PCI\n* According to IVUS assessment, the target lesions were dissected and accumulated medium without affecting distal blood flow\n\nExclusion Criteria:\n\n* \\<18 or \\>60 years old\n* Bridging vessels or stent restenosis\n* Unable to sign written informed consent\n* Female patients during pregnancy or lactation (for women who have not stopped menstruation, pregnancy test should be performed within 7 days prior to enrollment in this study)\n* Antiplatelet agents and anticoagulants are not available; Have heparin, contrast agent and other allergies\n* The subjects were participating in other uncompleted clinical trials\n* Scheduled elective surgery\n* Life expectancy is less than 1 year\n* Patients with high blood risk\n* Has long-term oral anticoagulant therapy adaptation\n* Cardiogenic shock\n* Patients with severe intraoperative dissection or hematoma requiring stent rescue'}, 'identificationModule': {'nctId': 'NCT05750758', 'briefTitle': 'Rivaroxaban Combined With DAPT Versus DAPT Alone After Drug-coated Balloon Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Henan Institute of Cardiovascular Epidemiology'}, 'officialTitle': 'A Randomized Controlled Trial of Rivaroxaban Combined With Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone 1 Month After Drug-coated Balloon Angioplasty in Patients With Acute Coronary Syndrome Without High Bleeding Risk', 'orgStudyIdInfo': {'id': 'HenanICE202203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAPT+rivaroxaban', 'description': 'Rivaroxaban 2.5 mg bid + aspirin 100 mg qd + ticagrelor 90 mg bid was used for 1 month after operation, and then aspirin 100 mg + ticagrelor 90 mg bid was used for 5 months.', 'interventionNames': ['Drug: rivaroxaban']}, {'type': 'NO_INTERVENTION', 'label': 'DAPT', 'description': 'aspirin 100 mg qd + ticagrelor 90 mg bid for 6 months.'}], 'interventions': [{'name': 'rivaroxaban', 'type': 'DRUG', 'description': 'rivaroxaban 2.5mg bid for 1m', 'armGroupLabels': ['DAPT+rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Fuwai central China cardiovascular Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Muwei Li, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai central China cardiovascular hospotial'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Institute of Cardiovascular Epidemiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}