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ST Elevation Myocardial InfarctionPhase 4HEALING-AMINCT02224534

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

A Phase 4 study testing Ticagrelor and Clopidogrel in people with ST Elevation Myocardial Infarction, run by Gyeongsang National University Hospital at 12 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
Ticagrelor and Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
12 sitesin 3 countries
Study dates
Oct 2014to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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.

Trial locations and contacts

12 sites in 3 countries.

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

12 sites in 3 countries

South Korea10 sites, 10 recruiting

  • Seoul National University Bundang Hospital

    Bundang, Gyeongki-do

    Jeong-Won Suh, MD, PhD

    Recruiting

  • Changwon Samsung Medical Center

    Changwon

    Ju Hyeon Oh, MD

    Recruiting

  • Chungbuk National University Hospital

    Chungju

    Sang Yeub Lee, MD.

    Recruiting

  • Kyungpook National University Hospital

    Daegu

    Jang Hoon Lee, MD

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Jae-Hyeong Park, MD.

    Recruiting

  • Chonnam National University Hospital

    Gwangju, CHONRANAM-Do

    Young-Joon Hong, MD, PhD

    Recruiting

  • Gyeongsang National University Hospital

    Korea, 660-702

    Yongwhi Park, MD.,PhD.

    Young-Hoon Jeong, MD.,PhD.

    Recruiting

  • Kyung Hee University Hospital

    Seoul

    Won Kim, MD.

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Eun-Seok Shin, MD.

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    Jeong Su Kim, MD.

    Recruiting

Other trials in South Korea

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing

    Yundai Chen, MD.

    Not yet recruiting

Other trials in China

Singapore1 site

  • National University Heart Centre

    Singapore

    Active, not recruiting

Other trials in Singapore

About this study

Official title: High PlatElet Inhibition With TicAgrelor to Improve Left Ventricular RemodeLING in Patients With ST-segment ElevAtion Myocardial Infarction: the HEALING-AMI Trial.

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.

Read the 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.

Being tested
Ticagrelor, Clopidogrel
Keywords
ST elevation myocardial infarction., Ticagrelor, Left ventricular remodeling, Platelet reactivity
Medical subject headings
ST Elevation Myocardial Infarction, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called Brillinta

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

  • ClopidogrelDrug

    Also called Plavix

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

Study groups in NCT02224534
Study groupRoleWhat they receive
Ticagrelor and Clopidogrel.ExperimentalThe 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.
Receives: Drug: Ticagrelor
ClopidogrelActive comparatorThe 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.
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Interval change between baseline and 6 months after the index events

  2. NT-proBNP level at 6 months

    Measured: 6 months after the index events

Secondary outcomes (3)

  1. Absolute change of LVESVI, LVEDVI and LVEF

    Measured: Interval change between baseline and 6 months after the index events

  2. 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.

    Measured: Interval change between baseline and 6 months after the index events

  3. Level of platelet reactivity

    Measured by VerifyNow P2Y12 assay

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
326 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02224534
Sponsor's protocol ID
D5130C00138
Acronym
HEALING-AMI
Status last verified
Nov 2016
First submitted
20 Aug 2014
Last updated
15 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 33032710

  • 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.

    PubMed 31074220

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Clopidogrel in people with ST Elevation Myocardial Infarction, run by Gyeongsang National University Hospital at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea, China, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongwhi Park, MD.,PhD. (+82-55-750-8059, angio2000@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LV remodeling index (%) (time frame: Interval change between baseline and 6 months after the index events). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224534, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.

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