Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-27 @ 8:44 PM
Study NCT ID:
NCT05986968
Status:
RECRUITING
Last Update Posted:
2024-09-23
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
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': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of major adverse cardiac and cerebral events (MACCE)', 'timeFrame': '1, 3 and 13 months after primary PCI', 'description': 'Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality'}, {'measure': 'Intramyocardial haemorrhage (IMH)', 'timeFrame': 'day 5-8 post primary PCI', 'description': 'Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.'}], 'secondaryOutcomes': [{'measure': 'Bleeding complications', 'timeFrame': '1, 3 and 13 months after primary PCI', 'description': 'Defined as Bleeding Academic Research Consortium (BARC) 2 or greater'}, {'measure': 'All-cause mortality', 'timeFrame': '1, 3 and 13 months after primary PCI'}, {'measure': 'Platelet reactivity', 'timeFrame': '5-8 days', 'description': 'Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured as Aspirin Reaction Units (ARU) using the VerifyNow test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and electrocardiographical diagnosis of STEMI\n* Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)\n\nExclusion Criteria:\n\n* Known allergy or contraindication for aspirin, ticagrelor or prasugrel.\n* Previous PCI or MI less than 12 months ago\n* Previous cardiac surgery\n* Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))\n* Pregnancy and breast feeding\n* Concurrent use of oral anticoagulants (OAC)\n* The periprocedural use of GPIIb/IIIa inhibitors\n* Planned surgical intervention within 12 months of PCI\n* Creatinine clearance \\<30mL/min or dialysis\n* PCI of stent thrombosis\n* Suboptimal stent result as judged by the interventional cardiologist.\n* Life expectancy shorter than 13 months.\n* Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).'}, 'identificationModule': {'nctId': 'NCT05986968', 'acronym': 'STOP-IMH', 'briefTitle': 'Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage', 'orgStudyIdInfo': {'id': 'NL82646.091.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)', 'interventionNames': ['Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.', 'interventionNames': ['Drug: Ticagrelor', 'Drug: Aspirin']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'description': 'Ticagrelor monotherapy for 12 months', 'armGroupLabels': ['Control arm', 'Treatment arm']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alkmaar', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ton Heestermans, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Noordwest Ziekenhuisgroep Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bimmer Claessen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Hans Van Rees, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Enschede', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Clemens Von Birgelen, MD, Prof', 'role': 'CONTACT'}], 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Peter Damman, MD, PhD, FESC', 'role': 'CONTACT'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Peter Damman, MD, PhD, FESC', 'role': 'CONTACT', 'email': 'peter.damman@radboudumc.nl', 'phone': '0031243616785'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}