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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02224534
Recruitment Status : Unknown
Verified November 2016 by Yongwhi Park, Gyeongsang National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 25, 2014
Last Update Posted : November 15, 2016
Sponsor:
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
Samsung Changwon Hospital
Kyunghee University Medical Center
Chungbuk National University Hospital
Chonnam National University Hospital
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Yongwhi Park, Gyeongsang National University Hospital

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.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: Ticagrelor Drug: Clopidogrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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.
Drug: Ticagrelor
Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose
Other Name: Brillinta

Active Comparator: 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.
Drug: Clopidogrel
Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.
Other Name: Plavix




Primary Outcome Measures :
  1. LV remodeling index (%) [ Time Frame: Interval change between baseline and 6 months after the index events ]

    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.


  2. NT-proBNP level at 6 months [ Time Frame: 6 months after the index events ]

Secondary Outcome Measures :
  1. Absolute change of LVESVI, LVEDVI and LVEF [ Time Frame: Interval change between baseline and 6 months after the index events ]
  2. Prevalence of adverse LV remodeling [ Time Frame: Interval change between baseline and 6 months after the index events ]
    Adverse LV remodeling: a relative > 20% increase in LVEDV seen at 6-month follow-up compared with the baseline during admission.

  3. Level of platelet reactivity [ Time Frame: At the time of PCI, 3 days and 1 month after the events ]
    Measured by VerifyNow P2Y12 assay


Other Outcome Measures:
  1. Post-PCI angiographic perfusion indicators: TIMI flow grade, myocardial blush grade, corrected TIMI frame count [ Time Frame: Just after primary PCI ]
  2. EKG change: ST-segment elevation resolution (%), complete ST-segment resolution [ Time Frame: Baseline, 60 minutes after the PCI. ]
    complete ST-segment resolution: ST-segment resolution ≥70%

  3. Level of hs-CRP [ Time Frame: At the time of PCI, 1 month and 6 months after the events ]
  4. Bleeding events based on BARC or PLATO definition [ Time Frame: 6 months after the events ]

    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.


  5. Cardiac MRI (Substudy): LV remodeling index [ Time Frame: Three days and 6 months after the events ]
    Measured at A*STAR-NUS Clinical Imaging Research Centre, Singapore

  6. Level of inflammatory markers (Substudy) [ Time Frame: During hospitalization and at 1 month after the events ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224534


Contacts
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Contact: Yongwhi Park, MD.,PhD. +82-55-750-8059 angio2000@hanmail.net
Contact: Young-Hoon Jeong, MD.,PhD. +82-55-214-3721 goodoctor@naver.com

Locations
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China
Chinese PLA General Hospital Not yet recruiting
Bejing, China
Principal Investigator: Yundai Chen, MD.         
Korea, Republic of
Chonnam National University Hospital Recruiting
Gwangju, CHONRANAM-Do, Korea, Republic of
Contact: Young-Joon Hong, MD, PhD         
Seoul National University Bundang Hospital Recruiting
Bundang, Gyeongki-do, Korea, Republic of
Contact: Jeong-Won Suh, MD, PhD         
Changwon Samsung Medical Center Recruiting
Changwon, Korea, Republic of
Principal Investigator: Ju Hyeon Oh, MD         
Chungbuk National University Hospital Recruiting
Chungju, Korea, Republic of
Principal Investigator: Sang Yeub Lee, MD.         
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Principal Investigator: Jang Hoon Lee, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Principal Investigator: Jae-Hyeong Park, MD.         
Gyeongsang National University Hospital Recruiting
Korea, Korea, Republic of, 660-702
Principal Investigator: Yongwhi Park, MD.,PhD.         
Principal Investigator: Young-Hoon Jeong, MD.,PhD.         
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Won Kim, MD.         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Principal Investigator: Eun-Seok Shin, MD.         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Principal Investigator: Jeong Su Kim, MD.         
Singapore
National University Heart Centre Active, not recruiting
Singapore, Singapore
Sponsors and Collaborators
Gyeongsang National University Hospital
Chinese PLA General Hospital
Chungnam National University Hospital
Pusan National University Yangsan Hospital
National University Heart Centre, Singapore
Ulsan University Hospital
Kyungpook National University
Samsung Changwon Hospital
Kyunghee University Medical Center
Chungbuk National University Hospital
Chonnam National University Hospital
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Yongwhi Park, MD., PhD. Gyeongsang National University Hospital
Principal Investigator: Young-Hoon Jeong, MD.,PhD. Gyeongsan National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yongwhi Park, MD.,PhD., Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT02224534    
Other Study ID Numbers: D5130C00138
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yongwhi Park, Gyeongsang National University Hospital:
ST elevation myocardial infarction.
Ticagrelor
Left ventricular remodeling
Platelet reactivity
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs