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Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction (HEALING-AMI)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
Gyeongsang National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST elevation myocardial infarction., Ticagrelor, Left ventricular remodeling, Platelet reactivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and older.
  • 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:

  • Previous history of myocardial infarction.
  • 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.

Sites / Locations

  • Chinese PLA General Hospital
  • Chonnam National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Changwon Samsung Medical CenterRecruiting
  • Chungbuk National University HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Kyung Hee University HospitalRecruiting
  • Ulsan University HospitalRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • National University Heart Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor and Clopidogrel.

Clopidogrel

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
NT-proBNP level at 6 months

Secondary Outcome Measures

Absolute change of LVESVI, LVEDVI and LVEF
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.
Level of platelet reactivity
Measured by VerifyNow P2Y12 assay

Full Information

First Posted
August 20, 2014
Last Updated
November 14, 2016
Sponsor
Gyeongsang National University Hospital
Collaborators
Chinese PLA General Hospital, Chungnam National University Hospital, Pusan National University Yangsan Hospital, National University Heart Centre, Singapore, Ulsan University Hospital, Kyungpook National University Hospital, Samsung Changwon Hospital, Kyunghee University Medical Center, Chungbuk National University Hospital, Chonnam National University Hospital, Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02224534
Brief Title
Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction
Acronym
HEALING-AMI
Official Title
High PlatElet Inhibition With TicAgrelor to Improve Left Ventricular RemodeLING in Patients With ST-segment ElevAtion Myocardial Infarction: the HEALING-AMI Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gyeongsang National University Hospital
Collaborators
Chinese PLA General Hospital, Chungnam National University Hospital, Pusan National University Yangsan Hospital, National University Heart Centre, Singapore, Ulsan University Hospital, Kyungpook National University Hospital, Samsung Changwon Hospital, Kyunghee University Medical Center, Chungbuk National University Hospital, Chonnam National University Hospital, Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
ST elevation myocardial infarction., Ticagrelor, Left ventricular remodeling, Platelet reactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor and Clopidogrel.
Arm Type
Experimental
Arm 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.
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brillinta
Intervention Description
Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.
Primary Outcome Measure Information:
Title
LV remodeling index (%)
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. 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.
Time Frame
Interval change between baseline and 6 months after the index events
Title
NT-proBNP level at 6 months
Time Frame
6 months after the index events
Secondary Outcome Measure Information:
Title
Absolute change of LVESVI, LVEDVI and LVEF
Time Frame
Interval change between baseline and 6 months after the index events
Title
Prevalence of adverse LV remodeling
Description
Adverse LV remodeling: a relative > 20% increase in LVEDV seen at 6-month follow-up compared with the baseline during admission.
Time Frame
Interval change between baseline and 6 months after the index events
Title
Level of platelet reactivity
Description
Measured by VerifyNow P2Y12 assay
Time Frame
At the time of PCI, 3 days and 1 month after the events
Other Pre-specified Outcome Measures:
Title
Post-PCI angiographic perfusion indicators: TIMI flow grade, myocardial blush grade, corrected TIMI frame count
Time Frame
Just after primary PCI
Title
EKG change: ST-segment elevation resolution (%), complete ST-segment resolution
Description
complete ST-segment resolution: ST-segment resolution ≥70%
Time Frame
Baseline, 60 minutes after the PCI.
Title
Level of hs-CRP
Time Frame
At the time of PCI, 1 month and 6 months after the events
Title
Bleeding events based on BARC or PLATO definition
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. Type 1 (nuisance or superficial bleeding). Type 2 (internal bleeding). Type 3a (TIMI minor bleeding). Type 3b (TIMI major bleeding). Type 3c (life threatening bleeding). Type 4 (CABG-related bleeding). Type 5a (probable fatal bleeding). 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. PLATO definition for bleeding Major life-threatening bleeding. Other major bleeding. Minor 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.
Time Frame
6 months after the events
Title
Cardiac MRI (Substudy): LV remodeling index
Description
Measured at A*STAR-NUS Clinical Imaging Research Centre, Singapore
Time Frame
Three days and 6 months after the events
Title
Level of inflammatory markers (Substudy)
Time Frame
During hospitalization and at 1 month after the events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older. 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: Previous history of myocardial infarction. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongwhi Park, MD.,PhD.
Phone
+82-55-750-8059
Email
angio2000@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Hoon Jeong, MD.,PhD.
Phone
+82-55-214-3721
Email
goodoctor@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongwhi Park, MD., PhD.
Organizational Affiliation
Gyeongsang National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young-Hoon Jeong, MD.,PhD.
Organizational Affiliation
Gyeongsan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Bejing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, MD.
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
CHONRANAM-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Joon Hong, MD, PhD
Facility Name
Seoul National University Bundang Hospital
City
Bundang
State/Province
Gyeongki-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Won Suh, MD, PhD
Facility Name
Changwon Samsung Medical Center
City
Changwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ju Hyeon Oh, MD
Facility Name
Chungbuk National University Hospital
City
Chungju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeub Lee, MD.
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang Hoon Lee, MD
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park, MD.
Facility Name
Gyeongsang National University Hospital
City
Korea
ZIP/Postal Code
660-702
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongwhi Park, MD.,PhD.
First Name & Middle Initial & Last Name & Degree
Young-Hoon Jeong, MD.,PhD.
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Kim, MD.
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Seok Shin, MD.
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Su Kim, MD.
Facility Name
National University Heart Centre
City
Singapore
Country
Singapore
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33032710
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.
Results Reference
derived
PubMed Identifier
31074220
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.
Results Reference
derived

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Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction

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