NCT02224534

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
326

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
3 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

August 20, 2014

Last Update Submit

November 14, 2016

Conditions

ST Elevation Myocardial Infarction

Keywords

ST elevation myocardial infarction.TicagrelorLeft ventricular remodelingPlatelet reactivity

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • Absolute change of LVESVI, LVEDVI and LVEF

    Interval change between baseline and 6 months after the index events

  • Prevalence of adverse LV remodeling

    Interval change between baseline and 6 months after the index events

  • Level of platelet reactivity

    At the time of PCI, 3 days and 1 month after the events

Other Outcomes (6)

  • 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

    Baseline, 60 minutes after the PCI.

  • Level of hs-CRP

    At the time of PCI, 1 month and 6 months after the events

  • +3 more other outcomes

Study Arms (2)

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.

Drug: Ticagrelor

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.

Drug: Clopidogrel

Interventions

TicagrelorDRUG

Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose

Also known as: Brillinta
Ticagrelor and Clopidogrel.
ClopidogrelDRUG

Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.

Also known as: Plavix
Clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Chinese PLA General Hospital

Beijing, China

NOT YET RECRUITING

National University Heart Centre

Singapore, Singapore

ACTIVE NOT RECRUITING

Chonnam National University Hospital

Gwangju, CHONRANAM-Do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Bundang, Gyeongki-do, South Korea

RECRUITING

Changwon Samsung Medical Center

Changwon, South Korea

RECRUITING

Chungbuk National University Hospital

Chungju, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Gyeongsang National University Hospital

Korea, 660-702, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, South Korea

RECRUITING

Related Publications (2)

  • 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: 33032710DERIVED

  • 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.

    PMID: 31074220DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionVentricular Remodeling

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yongwhi Park, MD., PhD.

    Gyeongsang National University Hospital

    PRINCIPAL INVESTIGATOR

  • Young-Hoon Jeong, MD.,PhD.

    Gyeongsan National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongwhi Park, MD.,PhD.

CONTACT

+82-55-750-8059angio2000@hanmail.net

Young-Hoon Jeong, MD.,PhD.

CONTACT

+82-55-214-3721goodoctor@naver.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.,PhD.

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 25, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(10)SG(1)CN(1)