Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT03435133
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size', 'timeFrame': '6 months', 'description': 'Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)'}], 'secondaryOutcomes': [{'measure': 'Infarct size', 'timeFrame': 'up to two weeks', 'description': 'Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)'}, {'measure': 'Myocardial salvage index', 'timeFrame': 'up to two weeks', 'description': 'Cardiac magnetic resonance imaging-assessed myocardial salvage index'}, {'measure': 'Microvascular obstruction', 'timeFrame': 'up to two weeks', 'description': 'Cardiac magnetic resonance imaging-assessed microvascular obstruction'}, {'measure': 'MACE', 'timeFrame': '6 months', 'description': 'The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary angioplasty', 'Prasugrel', 'Ticagrelor', 'STEMI', 'cardiac magnetic resonance', 'infarct size', 'infarct injury'], 'conditions': ['ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The investigators propose to perform a randomized clinical trial comparing prasugrel vs. ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The principal objective of the study would be analyzing the difference in myocardial infarction size measured by cardiac magnetic resonance at 6 months', 'detailedDescription': 'Dual antiplatelet therapy consisting of aspirin and one of the P2Y12 receptor inhibitors is the mainstay of treatment for patients with ST elevation acute myocardial infarction undergoing primary percutaneous coronary intervention. Prasugrel or ticagrelor have actually shown to be superior to clopidogrel improving the prognosis of these patients. However, the industrial interest has avoided any direct comparison between these two antiplatelets. Comparison is of great interest considering that only ticagrelor has shown to significantly reduce mortality. As ticagrelor may exert off-target effects through adenosine-related mechanisms, the investigators aimed to investigate whether ticagrelor reduces myocardial injury to a greater extent than prasugrel in patients with revascularized STEMI.\n\nPatients with acute STEMI undergoing primary percutaneous coronary revascularization within 6 hours of chest pain, will be randomized to (1) prasugrel (a 60 mg oral loading and a 10-mg dailiy maintenance dose) or to (2) ticagrelor (a 180 mg loading dose and a 90 mg twice daily maintenance dose). The predefined primary end point is infarct sieze on magnetic resonance imaging at the end of the study (6 months). Magnetic resonance will be performed at day 1, day 7 and moth 6. Platelet reactivity, biomarkers and clinical outcomes will also be assesed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older and equal or less than 75 years\n* symptom onset within 12 hours before random assignment\n* chest pain lasting more than 30 minutes\n* ST-segment elevation of at least 0.1 mV in at least 2 limb leads, ST-segment elevation of at least 0.2 mV in 2 or more contiguous precordial leads, or left bundle-branch block or paced rhythm\n* time from symptoms onset to randomization less than 6 hours\n* no severe heart failure (Killip class \\<3)\n* informed, written consent\n\nExclusion Criteria:\n\n* history of myocardial infarction with Q wave\n* history of surgical or percutaneous coronary revascularization\n* cardiogenic shock, defined as a systolic blood pressure \\<90 mm Hg with no response to fluid administration or \\<100 mm Hg in patients with supportive treatment and no bradycardia\n* history of stroke\n* history of bronchial asthma\n* symtomatic sinusal bradicardia or advance AV block\n* history of hypersensitivity to aspirin, prasugrel or ticagrelor or contraindication to the doses established in the study\n* patients pretreated with 600 mg of clopidogrel or more\n* contraindication for the use of gadolinium during the magenitc resonance'}, 'identificationModule': {'nctId': 'NCT03435133', 'acronym': 'COMPARE', 'briefTitle': 'Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI', 'organization': {'class': 'OTHER', 'fullName': 'AORTICA Group'}, 'officialTitle': 'Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients', 'orgStudyIdInfo': {'id': 'CARDIO2015.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prasugrel', 'interventionNames': ['Drug: Prasugrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ticagrelor', 'interventionNames': ['Drug: Ticagrelor']}], 'interventions': [{'name': 'Prasugrel', 'type': 'DRUG', 'description': '60 mg oral bolus plus oral 10 mg once daily', 'armGroupLabels': ['Prasugrel']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'description': '180 mg oral bolus plus oral 90 mg every 12 hours daily', 'armGroupLabels': ['Ticagrelor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Pedro Dorado', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'Pedro L Sanchez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Salamanca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AORTICA Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiology, PhD, MD', 'investigatorFullName': 'Pedro L Sanchez', 'investigatorAffiliation': 'AORTICA Group'}}}}