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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Chungnam National University Hospital | OTHER |
| Pusan National University Yangsan Hospital | OTHER |
| National University Heart Centre, Singapore |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor and Clopidogrel. | Experimental | 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. |
|
| Clopidogrel | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| LV remodeling index (%) | 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. Left 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. | Interval change between baseline and 6 months after the index events |
| NT-proBNP level at 6 months | 6 months after the index events |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change of LVESVI, LVEDVI and LVEF | Interval change between baseline and 6 months after the index events | |
| Prevalence of adverse LV remodeling | Adverse LV remodeling: a relative > 20% increase in LVEDV seen at 6-month follow-up compared with the baseline during admission. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-PCI angiographic perfusion indicators: TIMI flow grade, myocardial blush grade, corrected TIMI frame count | Just after primary PCI | |
| EKG change: ST-segment elevation resolution (%), complete ST-segment resolution | complete ST-segment resolution: ST-segment resolution ≥70% |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongwhi Park, MD.,PhD. | Contact | +82-55-750-8059 | angio2000@hanmail.net | |
| Young-Hoon Jeong, MD.,PhD. | Contact | +82-55-214-3721 | goodoctor@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongwhi Park, MD., PhD. | Gyeongsang National University Hospital | Principal Investigator |
| Young-Hoon Jeong, MD.,PhD. | Gyeongsan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Not yet recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33032710 | Derived | 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. | |
| 31074220 |
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| 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 |
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| Clopidogrel | Drug | Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose. |
|
|
| Interval change between baseline and 6 months after the index events |
| Level of platelet reactivity | Measured by VerifyNow P2Y12 assay | At the time of PCI, 3 days and 1 month after the events |
| Baseline, 60 minutes after the PCI. |
| Level of hs-CRP | At the time of PCI, 1 month and 6 months after the events |
| Bleeding events based on BARC or PLATO definition | 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.
PLATO definition for bleeding
The 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. | 6 months after the events |
| Cardiac MRI (Substudy): LV remodeling index | Measured at A*STAR-NUS Clinical Imaging Research Centre, Singapore | Three days and 6 months after the events |
| Level of inflammatory markers (Substudy) | During hospitalization and at 1 month after the events |
| National University Heart Centre | Active, not recruiting | Singapore | Singapore |
| Chonnam National University Hospital | Recruiting | Gwangju | CHONRANAM-Do | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Bundang | Gyeongki-do | South Korea |
|
| Changwon Samsung Medical Center | Recruiting | Changwon | South Korea |
|
| Chungbuk National University Hospital | Recruiting | Chungju | South Korea |
|
| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
|
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Gyeongsang National University Hospital | Recruiting | Korea | 660-702 | South Korea |
|
| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
|
| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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