Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 11:03 PM
Study NCT ID:
NCT02224534
Status:
UNKNOWN
Last Update Posted:
2016-11-15
First Post:
2014-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 326}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post-PCI angiographic perfusion indicators: TIMI flow grade, myocardial blush grade, corrected TIMI frame count', 'timeFrame': 'Just after primary PCI'}, {'measure': 'EKG change: ST-segment elevation resolution (%), complete ST-segment resolution', 'timeFrame': 'Baseline, 60 minutes after the PCI.', 'description': 'complete ST-segment resolution: ST-segment resolution ≥70%'}, {'measure': 'Level of hs-CRP', 'timeFrame': 'At the time of PCI, 1 month and 6 months after the events'}, {'measure': 'Bleeding events based on BARC or PLATO definition', 'timeFrame': '6 months after the events', 'description': 'BARC definition for bleeding is defined as type 1, 2, 3 (3a, 3b and 3c), 4, and 5 (5a and 5b), according to the Bleeding Academic Research Consortium classification.\n\n* Type 1 (nuisance or superficial bleeding).\n* Type 2 (internal bleeding).\n* Type 3a (TIMI minor bleeding).\n* Type 3b (TIMI major bleeding).\n* Type 3c (life threatening bleeding).\n* Type 4 (CABG-related bleeding).\n* Type 5a (probable fatal bleeding).\n* Type 5b (definite fatal bleeding). Bleeding events pertaining to type 1 to 3a are considered as minor bleeding and those pertaining to type 3b to 5b as major bleeding.\n\nPLATO definition for bleeding\n\n* Major life-threatening bleeding.\n* Other major bleeding.\n* Minor bleeding.\n\nThe case report form (CRF) collects the event history of bleeding during admission and at 1 month and 6 months. Occurrences of major, minor, and combined major and minor bleeding events will be compared between groups.'}, {'measure': 'Cardiac MRI (Substudy): LV remodeling index', 'timeFrame': 'Three days and 6 months after the events', 'description': 'Measured at A\\*STAR-NUS Clinical Imaging Research Centre, Singapore'}, {'measure': 'Level of inflammatory markers (Substudy)', 'timeFrame': 'During hospitalization and at 1 month after the events'}], 'primaryOutcomes': [{'measure': 'LV remodeling index (%)', 'timeFrame': 'Interval change between baseline and 6 months after the index events', 'description': 'Real time 3D-echocardiography data sets will be analyzed with available 4D-LV Analysis software (e.g. TomTec Imaging Systems, Unterschleisheim, Germany) in the core lab.\n\nLeft ventricular (LV) remodeling index: a relative change in LV end-diastolic volume (LVEDV) seen at 6-month follow-up compared with the baseline during admission.'}, {'measure': 'NT-proBNP level at 6 months', 'timeFrame': '6 months after the index events'}], 'secondaryOutcomes': [{'measure': 'Absolute change of LVESVI, LVEDVI and LVEF', 'timeFrame': 'Interval change between baseline and 6 months after the index events'}, {'measure': 'Prevalence of adverse LV remodeling', 'timeFrame': 'Interval change between baseline and 6 months after the index events', 'description': 'Adverse LV remodeling: a relative \\> 20% increase in LVEDV seen at 6-month follow-up compared with the baseline during admission.'}, {'measure': 'Level of platelet reactivity', 'timeFrame': 'At the time of PCI, 3 days and 1 month after the events', 'description': 'Measured by VerifyNow P2Y12 assay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ST elevation myocardial infarction.', 'Ticagrelor', 'Left ventricular remodeling', 'Platelet reactivity'], 'conditions': ['ST Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '33032710', 'type': 'DERIVED', 'citation': 'Park Y, Koh JS, Lee JH, Park JH, Shin ES, Oh JH, Chun W, Lee SY, Bae JW, Kim JS, Kim W, Suh JW, Yang DH, Hong YJ, Chan MY, Kang MG, Park HW, Hwang SJ, Hwang JY, Ahn JH, Choi SW, Jeong YH; HEALING-AMI Investigators. Effect of Ticagrelor on Left Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction (HEALING-AMI). JACC Cardiovasc Interv. 2020 Oct 12;13(19):2220-2234. doi: 10.1016/j.jcin.2020.08.007.'}, {'pmid': '31074220', 'type': 'DERIVED', 'citation': 'Park Y, Choi SW, Oh JH, Shin ES, Lee SY, Kim J, Kim W, Suh JW, Yang DH, Hong YJ, Chan MY, Koh JS, Hwang JY, Park JH, Jeong YH; HEALING-AMI Trial Investigators. Rationale and Design of the High Platelet Inhibition with Ticagrelor to Improve Left Ventricular Remodeling in Patients with ST-Segment Elevation Myocardial Infarction (HEALING-AMI) Trial. Korean Circ J. 2019 Jul;49(7):586-599. doi: 10.4070/kcj.2018.0415. Epub 2019 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the novel role of ticagrelor to improve long-term LV remodeling following ST-segment elevation myocardial infarction.', 'detailedDescription': 'The investigators designed the HEALING-AMI study to compare the influence of ticagrelor (180 mg loading and 90 mg twice daily maintenance) vs. clopidogrel (600 mg loading and 75 mg daily maintenance) on long-term left ventricular (LV) remodeling measured by 3D echocardiography in STEMI patients undergoing primary PCI.\n\nThe primary objective of the HEALING-AMI study is to demonstrate the novel role of long-term ticagrelor therapy in reducing the risk of LV remodeling,. The secondary objectives are to reveal the cross-talk between platelet and inflammatory process in ST-segment elevation myocardial infarction (STEMI) patients. Moreover, this study will determine whether the high platelet inhibition by ticagrelor culminate the protection of infarcted myocardium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older.\n* First-time onset STEMI patients uneventfully treated with primary PCI within 12 hours of onset of symptom.\n* Infarct-related artery with TIMI 0, 1, or 2 grade flow at the time of initial diagnostic angiography (before wire passage).\n* proximal or mid-portion lesion of epicardial coronary artery.\n\nExclusion Criteria:\n\n* Previous history of myocardial infarction.\n* Left bundle branch block on ECG at the time of screening.\n* Cardiogenic shock at the time of randomization.\n* Refractory ventricular arrhythmias or atrial fibrillation.\n* New York Heart Association class IV congestive heart failure.\n* Severe or malignant hypertension (SBP\\> 180 and/or DBP\\> 120 mmHg).\n* Fibrinolytic therapy.\n* History of hemorrhagic stroke.\n* Intracranial neoplasm, arteriovenous malformation, or aneurysm.\n* Ischemic stroke within 3 months prior to screening.\n* Platelet count \\< 100,000/mm3 or hemoglobin \\< 10 g/dL.\n* A need for oral anticoagulation therapy that cannot be safely discontinued for the duration of the study.\n* Women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding.\n* Unable to cooperate with protocol requirements and follow-up procedures.\n* A history of P2Y12 receptor inhibitor pretreatment (at least prior 1 month).\n* An increased risk of bradycardia.\n* Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer.'}, 'identificationModule': {'nctId': 'NCT02224534', 'acronym': 'HEALING-AMI', 'briefTitle': 'Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Gyeongsang National University Hospital'}, 'officialTitle': 'High PlatElet Inhibition With TicAgrelor to Improve Left Ventricular RemodeLING in Patients With ST-segment ElevAtion Myocardial Infarction: the HEALING-AMI Trial.', 'orgStudyIdInfo': {'id': 'D5130C00138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ticagrelor and Clopidogrel.', 'description': 'The patients assigned to the TICA group have loading dose of ticagrelor 180 mg just after the randomization, and then ticagrelor 90 mg twice daily during the study period. All patients also have aspirin 300 mg as a loading dose and 100 mg once daily as a maintenance dose.', 'interventionNames': ['Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel', 'description': 'The patients assigned to the CLPD group have loading dose of clopidogrel 600 mg just after the randomization, and then clopidogrel 75 mg daily should be maintained during the study period. All patients also have aspirin 300 mg as a loading dose and 100 mg once daily as a maintenance dose.', 'interventionNames': ['Drug: Clopidogrel']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brillinta'], 'description': 'Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose', 'armGroupLabels': ['Ticagrelor and Clopidogrel.']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.', 'armGroupLabels': ['Clopidogrel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yundai Chen, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Singapore', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Singapore', 'facility': 'National University Heart Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Gwangju', 'state': 'CHONRANAM-Do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Joon Hong, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Bundang', 'state': 'Gyeongki-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong-Won Suh, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hospital'}, {'city': 'Changwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ju Hyeon Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changwon Samsung Medical Center', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Chungju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Yeub Lee, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.97666, 'lon': 127.9287}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jang Hoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae-Hyeong Park, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '660-702', 'city': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yongwhi Park, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Young-Hoon Jeong, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gyeongsang National University Hospital'}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won Kim, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun-Seok Shin, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Yangsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong Su Kim, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Yongwhi Park, MD.,PhD.', 'role': 'CONTACT', 'email': 'angio2000@hanmail.net', 'phone': '+82-55-750-8059'}, {'name': 'Young-Hoon Jeong, MD.,PhD.', 'role': 'CONTACT', 'email': 'goodoctor@naver.com', 'phone': '+82-55-214-3721'}], 'overallOfficials': [{'name': 'Yongwhi Park, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gyeongsang National University Hospital'}, {'name': 'Young-Hoon Jeong, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gyeongsan National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, {'name': 'National University Heart Centre, Singapore', 'class': 'OTHER'}, {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Samsung Changwon Hospital', 'class': 'OTHER'}, {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, {'name': 'Chungbuk National University Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.,PhD.', 'investigatorFullName': 'Yongwhi Park', 'investigatorAffiliation': 'Gyeongsang National University Hospital'}}}}