Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 1:58 AM
Study NCT ID:
NCT04475835
Status:
UNKNOWN
Last Update Posted:
2022-05-02
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C074619', 'term': 'bivalirudin'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net adverse clinical events (NACE)', 'timeFrame': '30 days', 'description': 'A composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by BARC definition (grades 1-5).\n\nBARC=Bleeding Academic Research Consortium'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac and cerebral events (MACE)', 'timeFrame': '30 days', 'description': 'A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke'}, {'measure': 'Major adverse cardiac and cerebral events (MACE)', 'timeFrame': '6 months', 'description': 'A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke'}, {'measure': 'Bleeding', 'timeFrame': '30 days', 'description': 'Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred.\n\nBARC=Bleeding Academic Research Consortium'}, {'measure': 'Bleeding', 'timeFrame': '6 months', 'description': 'Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred.\n\nBARC=Bleeding Academic Research Consortium'}, {'measure': 'Stent thrombosis', 'timeFrame': 'Hospitalization', 'description': 'Stent thrombosis as defined by ARC ARC=Academic Research Consortium'}, {'measure': 'Stent thrombosis', 'timeFrame': '30 days', 'description': 'Stent thrombosis as defined by ARC ARC=Academic Research Consortium'}, {'measure': 'Stent thrombosis', 'timeFrame': '6 months', 'description': 'Stent thrombosis as defined by ARC ARC=Academic Research Consortium'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['STEMI With Multivessel Coronary Disease']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open label, cohort study, in which a total of 100 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention.\n\nNACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6 months after recruitment.', 'detailedDescription': "The 2017 guideline gives a class IIA recommendation ('should be considered') for complete revascularisation in patients presenting with STEMI and multivessel disease, which is approximately 50% of the STEMI population. Staged multivessel PCI during hospitalization (3-5 days after PPCI) is common in contemporary practice.\n\nPatients undergoing primary PCI should receive enhanced antithrombotic therapy, includes DAPT and and parenteral anticoagulant, which caused an increased bleeding risk. In addition, repeated use of heparin in a short time may increase the incidence of HIT. Direct thrombin inhibitor bivalirudin, demonstrated a reduced risk of bleeding and an overall favorable profile including reduced NACE.\n\nThis is a randomized, open label, cohort study, which is aimed to investigate the safety and efficacy of bivalirudin during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Acute STEMI (including patients within 12 h of symptom onset, or 24-48 h with recurrent or ongoing chest pain chest pain, persistent ST-segment elevation or new left bundle branch block.\n* Staged intervention of non-infarction related artery within 5 days after PPCI during Hospitalization.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Cardiogenic shock.\n* Received thrombolytic therapy or used any anticoagulant drugs within 48 hours before randomized.\n* Active bleeding, recent bleeding events or bleeding tendency.\n* History of surgery in the last 1 month.\n* Suspicious symptoms of aortic dissection, pericarditis and endocarditis.\n* Blood pressure \\> 180/110 mmHg.\n* Hemoglobin \\< 100 g/L, Platelet count \\<100×10(9)/L, Transaminase 3 times upper limit of normality or Creatinine clearance \\<30ml/min.\n* History of Heparin-Induced Thrombocytopenia.\n* Allergic to any research drug or device.\n* Pregnancy or lactation.\n* Any condition that makes the patient unsuitable for PCI or may interfere with the study.\n* Patient disagrees or fails to sign the written informed consent.'}, 'identificationModule': {'nctId': 'NCT04475835', 'briefTitle': 'Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'XJTU1AF2020LSK-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bivalirudin', 'description': 'Bivalirudin with prolonged full dose infusion during PCI', 'interventionNames': ['Drug: Bivalirudin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heparin', 'description': 'Heparin 100U/kg', 'interventionNames': ['Drug: Heparin']}], 'interventions': [{'name': 'Bivalirudin', 'type': 'DRUG', 'description': "Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \\<225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.", 'armGroupLabels': ['Bivalirudin']}, {'name': 'Heparin', 'type': 'DRUG', 'description': 'Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT \\<225 s (Hemotec method), an intravenous injection of heparin should be administered by need.', 'armGroupLabels': ['Heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yihui Xiao', 'role': 'CONTACT', 'email': 'sbw_514@163.com', 'phone': '+86-18220824850'}], 'facility': "First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yihui Xiao', 'role': 'CONTACT', 'email': 'sbw_514@163.com', 'phone': '+86-18220824850'}], 'overallOfficials': [{'name': 'Yihui Xiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}