Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT05210595
Status:
UNKNOWN
Last Update Posted:
2022-01-27
First Post:
2022-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Dosage of Ticagrelor in Korean Patients With AMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal platelet reactivity (OPR) rate', 'timeFrame': 'At 1 month', 'description': 'OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac and cerebrovascular events (MACCE)', 'timeFrame': 'At 9 months', 'description': 'MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke'}, {'measure': 'Bleeding events', 'timeFrame': 'At 9 months.', 'description': 'BARC: Bleeding Academic Research Consortium (BARC ≥2).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ticagrelor', 'De-escalation Strategy', 'Korean'], 'conditions': ['Acute Myocardial Infarction', 'Ticagrelor']}, 'descriptionModule': {'briefSummary': 'East Asian patients will be required optimal dose of newer P2Y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. Whether low dose of ticagrelorI is more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in Acute Myocardial Infarction (AMI) undergoing percutaneous coronary intervention(PCI).', 'detailedDescription': 'In recent years, newer oral P2Y12 receptor blocker (ticagrelor) has been strong recommendations for management of patients with AMI undergoing (PCI). This drug provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients present with acute myocardial infarction undergoing PCI.\n* Patients receiving ticagrelor; Male or female gender; Age 20-75 years.\n* Patients provide written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Low body weight (\\<60kg).\n* History of hemorrhagic stroke.\n* History of upper gastrointestinal bleeding in recent 6 months.\n* Bleeding tendency.\n* Thrombocytopenia defined by platelet \\< 100,000/ml.\n* Anemia defined by hemoglobin \\< 10 g/dl.\n* Renal dysfunction defined as serum creatinine \\> 2.5 mg/dl.\n* Severe hepatic dysfunction defined as serum transaminase \\> 3 times normal limit.\n* Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).\n* Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.'}, 'identificationModule': {'nctId': 'NCT05210595', 'briefTitle': 'Optimal Dosage of Ticagrelor in Korean Patients With AMI', 'organization': {'class': 'OTHER', 'fullName': 'Dong-A University'}, 'officialTitle': 'The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'HOPE-TAILOR 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Clopidogrel 75 mg/day as maintenance dose', 'interventionNames': ['Drug: Clopidogrel 75 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 1', 'description': 'De-escalation strategy dose receive ticagrelor 60 mg twice daily', 'interventionNames': ['Drug: Ticagrelor 60mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 2', 'description': 'De-escalation strategy dose receive ticagrelor 45 mg twice daily', 'interventionNames': ['Drug: Ticagrelor 45 mg']}], 'interventions': [{'name': 'Clopidogrel 75 mg', 'type': 'DRUG', 'otherNames': ['Plavix 75 mg'], 'description': '75 mg/day as maintenance dose.', 'armGroupLabels': ['Control group']}, {'name': 'Ticagrelor 60mg', 'type': 'DRUG', 'otherNames': ['Brilinta 60 mg'], 'description': 'In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 60 twice daily after discharge or post PCI 1 week.', 'armGroupLabels': ['Treatment group 1']}, {'name': 'Ticagrelor 45 mg', 'type': 'DRUG', 'otherNames': ['Brilinta 45 mg'], 'description': 'In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 45 twice daily after discharge or post PCI 1 week .', 'armGroupLabels': ['Treatment group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-715', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Moo Hyun Kim, M.D.', 'role': 'CONTACT', 'email': 'kimmh@dau.ac.kr', 'phone': '+82-51-240-2976'}, {'name': 'Moo Hyun Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DongA University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'centralContacts': [{'name': 'Moo Hyun Kim, MD', 'role': 'CONTACT', 'email': 'kimmh@dau.ac.kr', 'phone': '+82-51-240-2976'}], 'overallOfficials': [{'name': 'Moo Hyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Dept. of Cardiology Dong-A University Hospital', 'investigatorFullName': 'Moo Hyun Kim', 'investigatorAffiliation': 'Dong-A University'}}}}