Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT01813435
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2013-02-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Romania', 'Sweden']}, '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': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], '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'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pascal.vranckx@jessazh.be', 'phone': '+32 11 30 9589', 'title': 'Dr. Pascal Vranckx', 'organization': 'Jessa Ziekenhuis, Hasselt, Belgium'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'monitored for 2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy', 'otherNumAtRisk': 7980, 'deathsNumAtRisk': 7980, 'otherNumAffected': 0, 'seriousNumAtRisk': 7980, 'deathsNumAffected': 224, 'seriousNumAffected': 1459}, {'id': 'EG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for', 'otherNumAtRisk': 7988, 'deathsNumAtRisk': 7988, 'otherNumAffected': 0, 'seriousNumAtRisk': 7988, 'deathsNumAffected': 253, 'seriousNumAffected': 1543}], 'seriousEvents': [{'term': 'new Q-wave MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7980, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 7988, 'numAffected': 103}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7980, 'numAffected': 248}, {'groupId': 'EG001', 'numAtRisk': 7988, 'numAffected': 250}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7980, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 7988, 'numAffected': 164}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'revascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7980, 'numAffected': 739}, {'groupId': 'EG001', 'numAtRisk': 7988, 'numAffected': 793}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'definite stent thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7980, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 7988, 'numAffected': 64}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BARC 3 or 5 bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7980, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 7988, 'numAffected': 169}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '304', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 year', 'description': 'Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded. Data were censored 730 days after index percutaneous coronary intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Q-wave Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-year', 'description': 'shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Myocardial Revascularisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '739', 'groupId': 'OG000'}, {'value': '793', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Definite Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'OG000'}, {'value': '7988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'OG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'classes': [{'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 year', 'description': 'BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.\n\nType 3: Clinical, laboratory, and/or imaging evidence of bleeding with:\n\n* Type 3a:\n\n * Overt bleeding + Hb drop of 3 to \\< 5 g/dL (provided Hb drop is related to bleed)\n * Any transfusion with overt bleeding\n* Type 3b:\n\n * Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed)\n * Cardiac tamponade\n * Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)\n * Bleeding requiring intravenous vasoactive agents\n* Type 3c:\n\n * Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)\n * Subcategories confirmed by autopsy or imaging or lumbar puncture\n * Intraocular bleed compromising vision. Type 5: Fatal bleeding\n * Type 5a:\n\n • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious\n * Type 5b:\n\n * Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'FG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy\n\nClopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '12 participants withdrew consent or objected to use further use of data', 'groupId': 'FG000', 'numSubjects': '7980'}, {'comment': '11 participants withdrew consent or objected to use further use of data', 'groupId': 'FG001', 'numSubjects': '7988'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5810'}, {'groupId': 'FG001', 'numSubjects': '6981'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2170'}, {'groupId': 'FG001', 'numSubjects': '1007'}]}], 'dropWithdraws': [{'type': 'did not finish experimental regimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1902'}, {'groupId': 'FG001', 'numSubjects': '770'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '237'}]}]}], 'preAssignmentDetails': '12 participants of the experimental group withdrew consent or objected to use further use of data\n\n11 participants of the reference group withdrew consent or objected to use further use of data'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7980', 'groupId': 'BG000'}, {'value': '7988', 'groupId': 'BG001'}, {'value': '15968', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Treatment Strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)\n\nTicagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy'}, {'id': 'BG001', 'title': 'Reference Treatment Strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nAcetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3949', 'groupId': 'BG000'}, {'value': '3928', 'groupId': 'BG001'}, {'value': '7877', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4031', 'groupId': 'BG000'}, {'value': '4060', 'groupId': 'BG001'}, {'value': '8091', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '64.6', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1865', 'groupId': 'BG000'}, {'value': '1849', 'groupId': 'BG001'}, {'value': '3714', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6115', 'groupId': 'BG000'}, {'value': '6139', 'groupId': 'BG001'}, {'value': '12254', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'these are the numbers analysed for primary endpoint.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '527', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '854', 'groupId': 'BG000'}, {'value': '859', 'groupId': 'BG001'}, {'value': '1713', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '353', 'groupId': 'BG001'}, {'value': '705', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '475', 'groupId': 'BG000'}, {'value': '476', 'groupId': 'BG001'}, {'value': '951', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '337', 'groupId': 'BG001'}, {'value': '672', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '579', 'groupId': 'BG000'}, {'value': '580', 'groupId': 'BG001'}, {'value': '1159', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '1094', 'groupId': 'BG000'}, {'value': '1091', 'groupId': 'BG001'}, {'value': '2185', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '768', 'groupId': 'BG000'}, {'value': '764', 'groupId': 'BG001'}, {'value': '1532', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '790', 'groupId': 'BG000'}, {'value': '788', 'groupId': 'BG001'}, {'value': '1578', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '470', 'groupId': 'BG000'}, {'value': '473', 'groupId': 'BG001'}, {'value': '943', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '426', 'groupId': 'BG000'}, {'value': '423', 'groupId': 'BG001'}, {'value': '849', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1129', 'groupId': 'BG000'}, {'value': '1138', 'groupId': 'BG001'}, {'value': '2267', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15991}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2013-02-12', 'resultsFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-16', 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)', 'timeFrame': '2 year', 'description': 'Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With All-cause Mortality', 'timeFrame': '2-year'}, {'measure': 'Number of Participants With Myocardial Infarction', 'timeFrame': '2 year'}, {'measure': 'Number of Participants With New Q-wave Myocardial Infarction', 'timeFrame': '2-year'}, {'measure': 'Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction', 'timeFrame': '2-year', 'description': 'shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded'}, {'measure': 'Number of Participants With a Stroke', 'timeFrame': '2 year'}, {'measure': 'Number of Participants With a Myocardial Revascularisation', 'timeFrame': '2 year'}, {'measure': 'Number of Participants With a Definite Stent Thrombosis', 'timeFrame': '2 year'}, {'measure': 'Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding', 'timeFrame': '2 year', 'description': 'BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.\n\nType 3: Clinical, laboratory, and/or imaging evidence of bleeding with:\n\n* Type 3a:\n\n * Overt bleeding + Hb drop of 3 to \\< 5 g/dL (provided Hb drop is related to bleed)\n * Any transfusion with overt bleeding\n* Type 3b:\n\n * Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed)\n * Cardiac tamponade\n * Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)\n * Bleeding requiring intravenous vasoactive agents\n* Type 3c:\n\n * Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)\n * Subcategories confirmed by autopsy or imaging or lumbar puncture\n * Intraocular bleed compromising vision. Type 5: Fatal bleeding\n * Type 5a:\n\n • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious\n * Type 5b:\n\n * Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CAD', 'ACS', 'All comers', 'DAPT', 'PCI'], 'conditions': ['Coronary Artery Disease (CAD)']}, 'referencesModule': {'references': [{'pmid': '30166073', 'type': 'BACKGROUND', 'citation': 'Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.'}, {'pmid': '39875171', 'type': 'DERIVED', 'citation': "Woelders ECI, Onuma Y, Ninomiya K, O'Leary N, Damman P, Peeters DAM, Hof AWJV', Valgimigli M, Vranckx P, Windecker S, Serruys PWJC, van Geuns RM. Parsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy? Open Heart. 2025 Jan 28;12(1):e003083. doi: 10.1136/openhrt-2024-003083."}, {'pmid': '35260381', 'type': 'DERIVED', 'citation': 'Ono M, Hara H, Kawashima H, Gao C, Wang R, Wykrzykowska JJ, Piek JJ, Garg S, Hamm C, Steg PG, Valgimigli M, Windecker S, Vranckx P, Onuma Y, Serruys PW. Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial. EuroIntervention. 2022 Aug 5;18(5):e377-e388. doi: 10.4244/EIJ-D-21-00870.'}, {'pmid': '35229616', 'type': 'DERIVED', 'citation': 'Gragnano F, Zwahlen M, Vranckx P, Heg D, Schmidlin K, Hamm C, Steg PG, Gargiulo G, McFadden EP, Onuma Y, Chichareon P, Benit E, Mollmann H, Janssens L, Leonardi S, Zurakowski A, Arrivi A, Van Geuns RJ, Huber K, Slagboom T, Calabro P, Serruys PW, Juni P, Valgimigli M, Windecker S; GLOBAL LEADERS Investigators [Link]. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2022 May 17;11(10):e024291. doi: 10.1161/JAHA.121.024291. Epub 2022 Mar 1.'}, {'pmid': '35041147', 'type': 'DERIVED', 'citation': 'Westra J, Eftekhari A, Renkens M, Mejia-Renteria H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH. Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up. Int J Cardiovasc Imaging. 2022 Jun;38(6):1181-1190. doi: 10.1007/s10554-022-02522-1. Epub 2022 Jan 18.'}, {'pmid': '34533034', 'type': 'DERIVED', 'citation': 'Vranckx P, Valgimigli M, Odutayo A, Serruys PW, Hamm C, Steg PG, Heg D, Mc Fadden EP, Onuma Y, Benit E, Janssens L, Diletti R, Ferrario M, Huber K, Raber L, Windecker S, Juni P; GLOBAL LEADERS Investigators. Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.'}, {'pmid': '33066794', 'type': 'DERIVED', 'citation': 'Gao C, Tomaniak M, Takahashi K, Kawashima H, Wang R, Hara H, Ono M, Montalescot G, Garg S, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, van Geuns RJ, Hamm C, Steg PG, Onuma Y, Angiolillo DJ, Serruys PW. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial. Cardiovasc Diabetol. 2020 Oct 16;19(1):179. doi: 10.1186/s12933-020-01153-x.'}, {'pmid': '33065080', 'type': 'DERIVED', 'citation': 'Kawashima H, Tomaniak M, Ono M, Wang R, Hara H, Gao C, Takahashi K, Sharif F, Thury A, Suryapranata H, Walsh S, Cotton J, Carrie D, Sabate M, Steinwender C, Leibundgut G, Wykrzykowska J, de Winter RJ, Garg S, Hamm C, Steg PG, Juni P, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW. Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS). Am J Cardiol. 2021 Jan 1;138:1-10. doi: 10.1016/j.amjcard.2020.09.057. Epub 2020 Oct 13.'}, {'pmid': '32941872', 'type': 'DERIVED', 'citation': 'Gao C, Takahashi K, Garg S, Hara H, Wang R, Kawashima H, Ono M, Montalescot G, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, Hamm C, Steg PG, Storey R, van Geuns RJ, Tao L, Onuma Y, Serruys PW. Regional variation in patients and outcomes in the GLOBAL LEADERS trial. Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.'}, {'pmid': '32838554', 'type': 'DERIVED', 'citation': 'Hara H, Takahashi K, Kogame N, Tomaniak M, Kerkmeijer LSM, Ono M, Kawashima H, Wang R, Gao C, Wykrzykowska JJ, de Winter RJ, Neumann FJ, Plante S, Lemos Neto PA, Garg S, Juni P, Vranckx P, Windecker S, Valgimigli M, Hamm C, Steg PG, Onuma Y, Serruys PW. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2020 Sep;13(9):e009177. doi: 10.1161/CIRCINTERVENTIONS.120.009177. Epub 2020 Aug 25.'}, {'pmid': '32762446', 'type': 'DERIVED', 'citation': 'Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Juni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, Serruys PW; GLOBAL LEADERS Trial Investigators. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. Circ Cardiovasc Qual Outcomes. 2020 Aug;13(8):e006660. doi: 10.1161/CIRCOUTCOMES.120.006660. Epub 2020 Jul 30.'}, {'pmid': '32006156', 'type': 'DERIVED', 'citation': 'Ono M, Chichareon P, Tomaniak M, Kawashima H, Takahashi K, Kogame N, Modolo R, Hara H, Gao C, Wang R, Walsh S, Suryapranata H, da Silva PC, Cotton J, Koning R, Akin I, Rensing BJWM, Garg S, Wykrzykowska JJ, Piek JJ, Juni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial. Clin Res Cardiol. 2020 Sep;109(9):1125-1139. doi: 10.1007/s00392-020-01604-1. Epub 2020 Jan 31.'}, {'pmid': '31925529', 'type': 'DERIVED', 'citation': 'Tomaniak M, Chichareon P, Klimczak-Tomaniak D, Takahashi K, Kogame N, Modolo R, Wang R, Ono M, Hara H, Gao C, Kawashima H, Rademaker-Havinga T, Garg S, Curzen N, Haude M, Kochman J, Gori T, Montalescot G, Angiolillo DJ, Capodanno D, Storey RF, Hamm C, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW, Anderson R. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clin Res Cardiol. 2020 Jul;109(7):930-943. doi: 10.1007/s00392-019-01586-9. Epub 2020 Jan 10.'}, {'pmid': '31876907', 'type': 'DERIVED', 'citation': 'Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernandez Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, Serruys PW; GLOBAL LEADERS Study Investigators. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):222-230. doi: 10.1093/ehjcvp/pvz052.'}, {'pmid': '31845894', 'type': 'DERIVED', 'citation': 'Tomaniak M, Chichareon P, Modolo R, Takahashi K, Chang CC, Kogame N, Spitzer E, Buszman PE, van Geuns RM, Valkov V, Steinwender C, Geisler T, Prokopczuk J, Sabate M, Zmudka K, Rademaker-Havinga T, Tijssen JGP, Juni P, Hamm C, Steg PG, Onuma Y, Vranckx P, Valgimigli M, Windecker S, Baber U, Anderson R, Dominici M, Serruys PW. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial. EuroIntervention. 2020 Apr 3;15(18):e1605-e1614. doi: 10.4244/EIJ-D-19-00699.'}, {'pmid': '31693078', 'type': 'DERIVED', 'citation': 'Chichareon P, Modolo R, Kerkmeijer L, Tomaniak M, Kogame N, Takahashi K, Chang CC, Komiyama H, Moccetti T, Talwar S, Colombo A, Maillard L, Barlis P, Wykrzykowska J, Piek JJ, Garg S, Hamm C, Steg PG, Juni P, Valgimigli M, Windecker S, Onuma Y, Mehran R, Serruys PW. Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):21-29. doi: 10.1001/jamacardio.2019.4296.'}, {'pmid': '31623758', 'type': 'DERIVED', 'citation': 'Takahashi K, Serruys PW, Chichareon P, Chang CC, Tomaniak M, Modolo R, Kogame N, Magro M, Chowdhary S, Eitel I, Zweiker R, Ong P, Ottesen MM, Tijssen JGP, Wykrzykowska JJ, de Winter RJ, Garg S, Stoll HP, Hamm C, Steg PG, Onuma Y, Valgimigli M, Vranckx P, Carrie D, Windecker S. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI. J Am Coll Cardiol. 2019 Oct 22;74(16):2015-2027. doi: 10.1016/j.jacc.2019.08.997.'}, {'pmid': '31557763', 'type': 'DERIVED', 'citation': 'Tomaniak M, Chichareon P, Onuma Y, Deliargyris EN, Takahashi K, Kogame N, Modolo R, Chang CC, Rademaker-Havinga T, Storey RF, Dangas GD, Bhatt DL, Angiolillo DJ, Hamm C, Valgimigli M, Windecker S, Steg PG, Vranckx P, Serruys PW; GLOBAL LEADERS Trial Investigators. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial. JAMA Cardiol. 2019 Nov 1;4(11):1092-1101. doi: 10.1001/jamacardio.2019.3355.'}, {'pmid': '30888959', 'type': 'DERIVED', 'citation': 'Serruys PW, Tomaniak M, Chichareon P, Modolo R, Kogame N, Takahashi K, Chang CC, Spitzer E, Walsh SJ, Adlam D, Hildick-Smith D, Edes I, van de Harst P, Krackhardt F, Tijssen JGP, Rademaker-Havinga T, Garg S, Steg PG, Hamm C, Juni P, Vranckx P, Onuma Y, Verheugt FWA. Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial. EuroIntervention. 2019 Dec 20;15(12):e1090-e1098. doi: 10.4244/EIJ-D-19-00202.'}, {'pmid': '30852547', 'type': 'DERIVED', 'citation': 'Leonardi S, Franzone A, Piccolo R, McFadden E, Vranckx P, Serruys P, Benit E, Liebetrau C, Janssens L, Ferrario M, Zurakowski A, van Geuns RJ, Dominici M, Huber K, Slagboom T, Buszman P, Bolognese L, Tumscitz C, Bryniarski K, Aminian A, Vrolix M, Petrov I, Garg S, Naber C, Prokopczuk J, Hamm C, Steg G, Heg D, Juni P, Windecker S, Valgimigli M. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). BMJ Open. 2019 Mar 9;9(3):e026053. doi: 10.1136/bmjopen-2018-026053.'}], 'seeAlsoLinks': [{'url': 'http://dx.doi.org/10.1016/S0140-6736(18)31858-0', 'label': 'Pubmed Identifier 30166073'}]}, 'descriptionModule': {'briefSummary': 'After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.\n\nThere are two medication strategies:\n\n* Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR\n* Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely', 'detailedDescription': 'The study objective is to determine in all-comers patients undergoing percutaneous coronary intervention (PCI) under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave myocardial infarction (MI) compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.\n\nThe study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy.\n\nRandomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)).\n\nAll patients will be followed for a period of 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-"All comer" patients\n\n1. Age ≥18 years;\n2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);\n3. Able to provide informed consent and willing to participate in 2 year follow- up period.\n\nExclusion Criteria:\n\n1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;\n2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;\n3. Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);\n4. Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;\n5. Need for chronic oral anti-coagulation therapy;\n6. Active major bleeding or major surgery within the last 30 days;\n7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;\n8. Known stroke (any type) within the last 30 days;\n9. Known pregnancy at time of randomisation;\n10. Female who is breastfeeding at time of randomisation;\n11. Currently participating in another trial and not yet at its primary endpoint.'}, 'identificationModule': {'nctId': 'NCT01813435', 'briefTitle': 'GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'ECRI bv'}, 'officialTitle': 'GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation', 'orgStudyIdInfo': {'id': 'ECRI-12-001, 02EU11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental treatment strategy', 'description': 'All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.\n\nDosage and frequency:\n\nTicagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)', 'interventionNames': ['Drug: Ticagrelor', 'Drug: Acetylsalicylic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference treatment strategy', 'description': 'Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.\n\nDosage and frequency:\n\nBrilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd', 'interventionNames': ['Drug: Ticagrelor', 'Drug: Acetylsalicylic Acid', 'Drug: Clopidogrel']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brilique'], 'description': 'Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.', 'armGroupLabels': ['Experimental treatment strategy', 'Reference treatment strategy']}, {'name': 'Acetylsalicylic Acid', 'type': 'DRUG', 'otherNames': ['Aspirin', 'B01AC06'], 'description': 'Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy', 'armGroupLabels': ['Experimental treatment strategy', 'Reference treatment strategy']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix', 'B01AC04'], 'description': 'Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.\n\nStable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy', 'armGroupLabels': ['Reference treatment strategy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'country': 'Australia', 'facility': 'Research centre Brisbane, 6101', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Research centre Melbourne, 6104', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Research centre Melbourne, 6105', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Graz', 'country': 'Austria', 'facility': 'Research centre Graz, 4305', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Rsearch centre Innsbruck, 4303', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Research centre Linz, 4304', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Research centre Vienna, 4301', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Research centre Vienna, 4302', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'Research centre Aalst, 3201', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'Research centre Aalst, 3206', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Research centre Bonheiden, 3204', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Charleroi', 'country': 'Belgium', 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'country': 'Hungary', 'facility': 'Research centre Budapest, 3602', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research centre Budapest, 3603', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Research centre Debrecen, 3607', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Gyula', 'country': 'Hungary', 'facility': 'Research centre Gyula, 3606', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Research centre Nyíregyháza, 3605', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'Research centre Pécs, 3604', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'Research centre szeged, 3601', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Arezzo', 'country': 'Italy', 'facility': 'Research centre 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