Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-09 @ 10:50 AM
Study NCT ID:
NCT02294994
Status:
UNKNOWN
Last Update Posted:
2014-12-02
First Post:
2014-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077466', 'term': 'Tirofiban'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-29', 'studyFirstSubmitDate': '2014-11-16', 'studyFirstSubmitQcDate': '2014-11-16', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net Adverse Clinical Events', 'timeFrame': '30 days', 'description': 'A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings'}], 'secondaryOutcomes': [{'measure': 'Net adverse clinical events', 'timeFrame': '1 year', 'description': 'a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings'}, {'measure': 'any bleedings (BARC class)', 'timeFrame': '30 days', 'description': 'including all BARC class (class 1-5)'}, {'measure': 'Major adverse cardiac and cerebral events (MACCE)', 'timeFrame': '30 days and 1 year', 'description': 'a composite of all cause death, reinfarction, target vessel revascularization or stroke'}, {'measure': 'stent thrombosis', 'timeFrame': '30 days and 1 year', 'description': 'by ARC definition'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score\\>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent\n* Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI\n* Experienced ischaemic pain at rest\n* Lasting 10 minutes and occurring within 7 days before enrollment\n* As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (\\< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads -Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference -\n* High-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score \\> 26 and chronic total occlusion disease.\n\nExclusion Criteria:\n\n* Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;\n* Recent (\\<1 month) trauma or major surgery (including bypass surgery);\n* Active bleeding\n* Unexplained clinically significant bleeding, thrombocytopenia (platelet count \\< 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy\n* Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure \\> 180 mm Hg despite treatment)\n* Valvular disease, congenital heart disease, hypertrophic cardiomyopathy, - Thrombolytic therapy within preceding 24 hours\n* Receiving antiIIb/IIIa therapy\n* Creatinine clearance of \\<30 mL/min'}, 'identificationModule': {'nctId': 'NCT02294994', 'briefTitle': 'Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Jilin University'}, 'officialTitle': 'Randomized Controlled Clinical Study to Compare the Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'SecondJilinU-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'half dose tirofiban', 'description': 'Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.075 µg per kilogram per minute for 24 to 36 hours.UFH heparin was administered as a bolus of 100 U/kg before PCI.', 'interventionNames': ['Drug: tirofiban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'recommended-dose Tirofiban', 'description': 'Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.15 µg per kilogram per minute for 18 to 24 hours. UFH heparin was administered as a bolus of 100 U/kg before PCI.', 'interventionNames': ['Drug: tirofiban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'none tirofiban', 'description': 'Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.', 'interventionNames': ['Drug: tirofiban']}], 'interventions': [{'name': 'tirofiban', 'type': 'DRUG', 'otherNames': ['GPIIb/IIIa inhibitor', 'aggrastat'], 'armGroupLabels': ['half dose tirofiban', 'none tirofiban', 'recommended-dose Tirofiban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Bin, M.D.', 'role': 'CONTACT', 'email': 'liubin3333@vip.sina.com', 'phone': '+86 13500810268'}], 'facility': 'The sencond hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Liu Bin, M.D.', 'role': 'CONTACT', 'email': 'liubin3333@vip.sina.com', 'phone': '+86 13500810268'}], 'overallOfficials': [{'name': 'Liu Bin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jilin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}