Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction
NCT ID: NCT02224534
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
326 participants
INTERVENTIONAL
2014-10-31
2017-12-31
Brief Summary
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Detailed Description
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The 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ticagrelor and Clopidogrel.
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.
Ticagrelor
Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose
Clopidogrel
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.
Clopidogrel
Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.
Interventions
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Ticagrelor
Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose
Clopidogrel
Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First-time onset STEMI patients uneventfully treated with primary PCI within 12 hours of onset of symptom.
* Infarct-related artery with TIMI 0, 1, or 2 grade flow at the time of initial diagnostic angiography (before wire passage).
* proximal or mid-portion lesion of epicardial coronary artery.
Exclusion Criteria
* Left bundle branch block on ECG at the time of screening.
* Cardiogenic shock at the time of randomization.
* Refractory ventricular arrhythmias or atrial fibrillation.
* New York Heart Association class IV congestive heart failure.
* Severe or malignant hypertension (SBP\> 180 and/or DBP\> 120 mmHg).
* Fibrinolytic therapy.
* History of hemorrhagic stroke.
* Intracranial neoplasm, arteriovenous malformation, or aneurysm.
* Ischemic stroke within 3 months prior to screening.
* Platelet count \< 100,000/mm3 or hemoglobin \< 10 g/dL.
* A need for oral anticoagulation therapy that cannot be safely discontinued for the duration of the study.
* Women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding.
* Unable to cooperate with protocol requirements and follow-up procedures.
* A history of P2Y12 receptor inhibitor pretreatment (at least prior 1 month).
* An increased risk of bradycardia.
* Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer.
18 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Chungnam National University Hospital
OTHER
Pusan National University Yangsan Hospital
OTHER
National University Heart Centre, Singapore
OTHER
Ulsan University Hospital
OTHER
Kyungpook National University Hospital
OTHER
Samsung Changwon Hospital
OTHER
Kyunghee University Medical Center
OTHER
Chungbuk National University Hospital
OTHER
Chonnam National University Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Gyeongsang National University Hospital
OTHER
Responsible Party
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Yongwhi Park
MD.,PhD.
Principal Investigators
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Yongwhi Park, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
Gyeongsang National University Hospital
Young-Hoon Jeong, MD.,PhD.
Role: PRINCIPAL_INVESTIGATOR
Gyeongsan National University Hospital
Locations
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Chinese PLA General Hospital
Beijing, , China
National University Heart Centre
Singapore, , Singapore
Chonnam National University Hospital
Gwangju, CHONRANAM-Do, South Korea
Seoul National University Bundang Hospital
Bundang, Gyeongki-do, South Korea
Changwon Samsung Medical Center
Changwon, , South Korea
Chungbuk National University Hospital
Chungju, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Gyeongsang National University Hospital
Korea, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Young-Joon Hong, MD, PhD
Role: primary
Jeong-Won Suh, MD, PhD
Role: primary
References
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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.
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.
Other Identifiers
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D5130C00138
Identifier Type: -
Identifier Source: org_study_id