Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT01519518
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2012-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'C074619', 'term': 'bivalirudin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rod.stables@lhch.nhs.uk', 'phone': '01512281616', 'title': 'Dr Rod Stables', 'phoneExt': '1489', 'organization': 'Liverpool Heart and Chest Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Unfractionated Heparin', 'description': '70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}, {'value': '905', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unfractionated Heparin', 'description': '70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous'}, {'id': 'OG001', 'title': 'Bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'percentage of total participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}, {'value': '905', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unfractionated Heparin', 'description': '70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous'}, {'id': 'OG001', 'title': 'Bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'percentage of total participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure', 'timeFrame': '28 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}, {'value': '905', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unfractionated Heparin', 'description': '70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous'}, {'id': 'OG001', 'title': 'Bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'percentage of total participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stent Thrombosis Rate (ARC Definite or Probable)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}, {'value': '905', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unfractionated Heparin', 'description': '70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous'}, {'id': 'OG001', 'title': 'Bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'percentage of total participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes', 'timeFrame': '28 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Development of Thrombocytopenia', 'timeFrame': '28 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Door-to-first Device Time', 'timeFrame': '28 days', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unfractionated Heparin', 'description': '70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous'}, {'id': 'FG001', 'title': 'Bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '914'}, {'groupId': 'FG001', 'numSubjects': '915'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '907'}, {'groupId': 'FG001', 'numSubjects': '905'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Consent not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'BG000'}, {'value': '905', 'groupId': 'BG001'}, {'value': '1812', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Unfractionated Heparin', 'description': '70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous'}, {'id': 'BG001', 'title': 'Bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'groupId': 'BG000', 'lowerLimit': '54.0', 'upperLimit': '73.8'}, {'value': '62.9', 'groupId': 'BG001', 'lowerLimit': '53.7', 'upperLimit': '74'}, {'value': '63.2', 'groupId': 'BG002', 'lowerLimit': '53.9', 'upperLimit': '73.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '663', 'groupId': 'BG000'}, {'value': '647', 'groupId': 'BG001'}, {'value': '1310', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1829}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-24', 'studyFirstSubmitDate': '2012-01-24', 'resultsFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-07', 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization', 'timeFrame': '28 days'}, {'measure': 'Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure', 'timeFrame': '28 days'}, {'measure': 'Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition', 'timeFrame': '28 days'}, {'measure': 'Stent Thrombosis Rate (ARC Definite or Probable)', 'timeFrame': '28 days'}, {'measure': 'For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes', 'timeFrame': '28 days'}, {'measure': 'All Cause Mortality', 'timeFrame': '1 year'}, {'measure': 'Development of Thrombocytopenia', 'timeFrame': '28 days'}, {'measure': 'Door-to-first Device Time', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ST elevation myocardial infarction', 'Primary percutaneous coronary intervention', 'Unfractionated heparin', 'Bivalirudin', 'primary angioplasty'], 'conditions': ['Acute ST Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '25002178', 'type': 'DERIVED', 'citation': 'Shahzad A, Kemp I, Mars C, Wilson K, Roome C, Cooper R, Andron M, Appleby C, Fisher M, Khand A, Kunadian B, Mills JD, Morris JL, Morrison WL, Munir S, Palmer ND, Perry RA, Ramsdale DR, Velavan P, Stables RH; HEAT-PPCI trial investigators. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. Lancet. 2014 Nov 22;384(9957):1849-1858. doi: 10.1016/S0140-6736(14)60924-7. Epub 2014 Jul 4.'}, {'pmid': '24219045', 'type': 'DERIVED', 'citation': 'Malik N, Gershlick AH. The clinical and economic impact of bivalirudin for percutaneous coronary intervention. Expert Rev Pharmacoecon Outcomes Res. 2013 Dec;13(6):699-706. doi: 10.1586/14737167.2013.844650.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the performance and subsequent outcomes of Primary percutaneous coronary intervention. This will be a pragmatic trial. Interventional procedures will be performed to reflect current and evolving standards, including predominant radial access. All patients will be treated with routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for 'bail out' treatment only.", 'detailedDescription': 'HEAT-PPCI is a single-centre prospective, dual-arm, open-label, randomised controlled trial comparing two antithrombotic agents in patients undergoing PPCI. All patients presenting to the PPCI service at Liverpool Heart and Chest Hospital will be assessed for trial eligibility. The patients will be allocated by randomisation in equal proportions to the two treatment groups receiving UFH (70 units/kg prior to the procedure) or bivalirudin (bolus of 0.75 mg/kg prior to the start of the intervention, followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure).\n\nPre-Specified Subgroup Analyses\n\n* Subgroup analyses looking at the impact of access site comparing radial versus femoral route\n* Assessment of the outcomes in diabetic patients receiving oral hypoglycaemic or insulin therapy versus all other patients\n* Comparing the outcomes in patients \\< or ≥ 75 years of age\n* Type of p2y12 receptor inhibiting antiplatelet agent (Examples: clopidogrel, prasugrel, ticagrelor)\n* Patients with impaired LV function versus normal LV function\n* Patients managed with actual or attempted primary PCI versus no immediate PCI procedure attempted\n\nPLATELET FUNCTION SUBSTUDY A substudy will be performed to assess indices of coagulation and platelet function studies comparing the impact of heparin or bivalirudin therapy on coagulation status at the end of the PPCI procedure. This study will be performed on all patients treated between the hours of 0800 and 1600, Monday to Friday. A single blood sample taken at the time of general blood sampling for routine clinical screening will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial\n\nExclusion Criteria:\n\n* ≤ 18 years of age\n* Known intolerance, hypersensitivity or contraindication to any trial medication\n* Active bleeding at presentation\n* Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy\n* Previous enrolment in this trial'}, 'identificationModule': {'nctId': 'NCT01519518', 'acronym': 'HEAT-PPCI', 'briefTitle': 'How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool Heart and Chest Hospital NHS Foundation Trust'}, 'officialTitle': 'A Randomised Controlled Trial to Compare Unfractionated Heparin Versus Bivalirudin in the Treatment of Patients With a Clinical Diagnosis of ST-Segment Elevation Myocardial Infarction Events - For Planned Management With Primary PCI', 'orgStudyIdInfo': {'id': '923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unfractionated heparin', 'description': '70 units/kg body weight intravenous', 'interventionNames': ['Drug: unfractionated heparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bivalirudin', 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour', 'interventionNames': ['Drug: Bivalirudin']}], 'interventions': [{'name': 'unfractionated heparin', 'type': 'DRUG', 'otherNames': ['UFH'], 'description': '70 units/kg body weight intravenous', 'armGroupLabels': ['Unfractionated heparin']}, {'name': 'Bivalirudin', 'type': 'DRUG', 'otherNames': ['Angiox'], 'description': 'intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour', 'armGroupLabels': ['bivalirudin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L14 3PE', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Rod Stables, MA DM FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liverpool Heart and Chest Hospital, Liverpool, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool Heart and Chest Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Dr Rod Stables', 'investigatorAffiliation': 'Liverpool Heart and Chest Hospital NHS Foundation Trust'}}}}