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Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis (TREAT)

Primary Purpose

Acute ST Segment Elevation Myocardial Infarction, Thrombolysis in Myocardial Infarction Flow

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ticagrelor 180 mg
Clopidogrel
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST Segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of both sexes aged ≥ 18 years and < 75 years with ACS with ST segment elevation with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of > 10 minutes duration at rest, treated with pharmacological thrombolysis
  • Fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours

Patients with acute coronary syndrome with ST segment elevation will be included provided they present ST segment elevation at the J point in two contiguous leads in electrocardiogram with cut-points: > 0.1mV in all leads other than leads V2-V3, where the following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or >0.15 mV in women and at least 1 of the following criteria:

  • Angina-like chest pain or ischemic equivalent chest pain;
  • Abnormalities above the reference value for markers of myocardial necrosis (troponin and CK-MB).

The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.

Exclusion Criteria:

  • Any contraindication against the use of clopidogrel (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, history of intracranial hemorrhage)
  • Need for oral anticoagulation therapy,
  • Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine)
  • Increased risk of bradycardia events
  • Dialysis required
  • Known clinically important thrombocytopenia
  • Known clinically important anemia
  • Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer)
  • Participant in another investigational drug or device study within 30 d
  • Pregnancy or lactation
  • Any condition that increases the risk for noncompliance or being lost to follow-up
  • Involvement in the planning or conduct of the study
  • Previous enrollment or randomization in this study

  • Contraindications to fibrinolytic therapy including: 15

    • Any prior intracranial hemorrhage
    • Known structural cerebral vascular lesion (eg, Arterial Venous Malformation - AVM)
    • Known malignant intracranial neoplasm (primary or metastatic)
    • Ischemic stroke within 3 months
    • Suspected aortic dissection
    • Active bleeding or bleeding diathesis (excluding menses)
    • Significant closed head trauma or facial trauma within 3 months

Sites / Locations

  • Hospital Interzonal General de Agudos Dr, José Penna
  • Hospital Alvarez
  • Hospital Del Cruce Nestor Kishner
  • Hospital Español de La Plata
  • Sanatorio Modelo de Quilmes
  • Hospital Zenón Santillan
  • Flinders Medical Centre
  • Royal Adelaide Hospital
  • Cairns Hospital
  • The Alfred Hospital
  • Mildura Hospital
  • John Hunter Hospital
  • Fiona Stanley Hospital
  • Liverpool Hospital
  • Townsville Hospital
  • Wollongong Hospital
  • Hospital das Clínicas - UFMG
  • Hospital Lifecenter
  • Hospital Universitario Sao Jose
  • Santa Case de Belo Horizonte
  • Hospital de Base do Distrito Federal
  • Instituto de Cardiologia do Distrito Federal
  • Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP
  • Hospital e Maternidade Celso Pierro
  • Hospital e Clinica Sao Roque
  • Hospital e Pronto Socorro 28 de Agosto
  • Hospital de Messejana
  • Santa Casa de Montes Claros
  • Hospital Sao Vicente de Paulo
  • Hospital Pronto Socorro e Maternidade Santa Lucia
  • Instituto de Cardiologia - Fundação de Cardiologia (ICFUC)
  • Hospital Agamenon Magalhaes
  • Hospital Municipal de Emergencia Albert Sabin
  • Santa Casa de Sao Jose do Rio Preto
  • Hospital do Coracao
  • Hospital do Mandaqui
  • Hospital Geral do Grajau / UNISA
  • Hospital Municipal do Campo Limpo
  • Hospital TotalCor
  • PreventSenior
  • Universidade Federal de Sao Paulo
  • Cardiolima
  • Royal Alexandra Hospital
  • University of Alberta Hospital
  • Queen Elizabeth II Health Sciences Centre
  • University Hospital / London Health Sciences Centre - Interventional Cardiology
  • Southlake Regional Health Centre - Interventional Cardiology
  • University of Ottawa Heart Institute
  • Peterborough Regional Health Centre
  • Inst Uni de Cardiologie et Pneumologie de Quebec
  • Regina General Hospital - Prairie Vascular Research Network (PVRN) - SETFAST Coordinating Centre (SCC)
  • New Brunswick Heart Centre Research Initiative
  • Centre Hospitalier Universitaire de Sherbrooke
  • Thunder Bay Regional Health Sciences Centre - Cardiac Cath Lab
  • Centre Intégré Universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
  • Victoria Heart Institute Foundation
  • St. Mary's General Hospital
  • Windsor Regional Hospital
  • St. Boniface General Hospital
  • Alxa League Central Hospital
  • Anshan Changda Hospital
  • Third affiliated hospital of Inner Mongolia medical university
  • Urad Front Banner People's Hospital
  • The First Hospital of Fangshan District, Beijing
  • Benxi Jinshan Hospital
  • Binzhou City Center Hospital
  • Changyuan County People's Hospital
  • Chaoyang Second People's Hospital
  • Dengfeng People's Hospital
  • Dunhua Hospital
  • Fushun Mining Bureau General Hospital
  • Gongyi People's Hospital
  • Hulunbuir People's Hospital
  • Qi County People's Hospital
  • Heze Municipal Hospital
  • Hunchun People's Hospital
  • Wen Country People´s Hospital
  • Laixi People's Hospital
  • The Second Hospital of Liaocheng
  • The Third People's Hospital of LiaoYang
  • Dongfeng County Hospital
  • Houma People's Hospital
  • Lingbao First People's Hospital
  • Ruyang People's Hospital
  • Anhui Province Mengcheng County, People's Hospital
  • Puyang Zhongyuan Oil field General Hospital
  • Qinyang People's Hospital
  • Sanmenxia Central Hospital
  • Shangqiu Changzheng People's Hospital
  • Shenyang Sujiatun District Central Hospital
  • Shenyang the Fourth Hospital of People
  • Xinmin People's Hospital
  • Jingxing County Hospital
  • Laoting Hospital
  • Wuchuan People's Hospital
  • Wuhai People's Hospital
  • Affiliated PuAi Hospital of Tongji Medical College
  • Wuyishan Municipal Hospital
  • Qinghai Cardiovascular Hospital
  • Feng County People's Hospita
  • Yongcheng People's Hospital
  • Jiang Hua Yao Autonomous County People's Hospital
  • The First People's Hospital of YueYang
  • Zhangye People's Hospital
  • Dancheng County People's Hospital
  • Huaiyang County People's Hospital
  • Foundation Cardiomet Cequin
  • Centro de Diagnostico Cardiologico Ltda
  • Hawkes Bay Hospital
  • Nelson Hospital
  • Taranaki Hospital
  • Rotorua Hospital
  • Tauranga Hospital
  • Thames Hospital
  • Whangarei Base Hopsital
  • Hospital Regional Lamabayeque
  • Clínica Internacional
  • Clínica San Pablo
  • Hospital Cayetano Heredia
  • Hospital Hipólito Unanue
  • Regional State Budget Healthcare Institution Altai Regional Cardiology Dispensary
  • State Healthcare Institution "Belgorod regional clinical hospital named after Prelate Ioasaf
  • State Budget Healthcare Institution "Chelyabinsk regional clinical hospital #3"
  • State Budget Healthcare Institution Leningrad region Gatchina Clinical Inter-district Hospital
  • State Healthcare Institution Irkutsk regional clinical hospital
  • Kirov Regional State Budget Healthcare Institution Kirov City clinical hospital #1
  • Regional State Budget Healthcare Institution Krasnoyarsk Regional Clinical Hospital
  • Municipal Healthcare Institution Lyubertsy regional Hospital #2
  • State Regional Budget Healthcare Institution Murmansk region Clinical Hospital named after P.A. Bayandin
  • State Budget Healthcare Institution Novosibirsk region City Clinical Hospital #34
  • Institution of the Russian academy of sciences Hospital of Pushchino Research Center of RAS
  • Municipal Budget Healthcare Institution Rostov-on-Don City Emergency Care Hospital
  • State Budget Healthcare Institution Ryazan region Regional Clinical Hospital
  • State Budget Educational Institution of Higher Professional Education "Smolensk State Medical University" Ministry of Healthcare of Russian Federation, clinical facility is State Budget Healthcare Institution "Smolensk regional clinical hospital"
  • Federal State Budget Science Institution "Science and Research Institute of Cardiology"
  • State Healthcare Institution of Tula Region "Tula regional clinical hospital
  • Tver Regional Clinical Hospital
  • State Budget Healthcare Institution Vladimir region City Hospital #4
  • Budget Healthcare Institution Voronezh region City Clinical Emergency Care Hospital #1
  • State Budget Healthcare Institution of Yaroslavl region "Regional clinical hospital"
  • Cherkasy Regional Cardiology Center, Department of Acute Heart Failure and Arrythmia
  • Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Department of Anestesiology and Intensive Care, SI"Ivano-Frankivsk National Medical University", Chair of Internal Medicine №2 and nurcering
  • Municipal Healthcare Institution "Kharkiv City Clinical Hospital #8", Cardiology Department for MI patients N1, Kharkiv Medical Academy of Postgraduate Education
  • SI "National Institut of Therapy named after L.T. Malaya NAMS of Ukraine", Department of Acute Myocardial Infarction
  • Kiev Oleksandrivsk Clinical Hospital, department of Cardiology Reanimation, National Medical University named after O.O. Bogomolets, Chair of Internal Medicine №2
  • Kyiv City Clinical Hospital #1, Department of Emergency Cardiology
  • Kyiv Emergency Care Hospital, Infarction Department
  • City Clinical Hospital # 1
  • MI "City Clinical Hospital N3 named after prof. K.J. Alejnikovoi", department of intensice cardiology care unit
  • MI "Rivne Regional Clinical Hospital"
  • Sumy regional Cardiology Dispensary
  • MI "Regional Medical Center of Cardiovascular Diseases" of Zaporizhzhia Regional Council, Intensive Care Unit
  • Municipal Institution " Central city clinical hospital N1", cardiology department for MI patients

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ticagrelor 180 mg

Clopidogrel

Arm Description

Patients assigned to Ticagrelor will receive oral Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.

Patients will take the 300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months. For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.

Outcomes

Primary Outcome Measures

Safety Outcome as a measure of Time to TIMI-defined first major bleeding
The primary safety endpoint is time to TIMI-defined and adjudicated first major bleeding event (including major life-threatening bleeding and other major bleeding). Bleeding TIMI Definition Major: Any intracranial hemorrhage (ICH)*, OR Clinically significant overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of ≥ 5 g/dL (or, when Hgb is not available, an absolute drop in hematocrit (Hct) of ≥ 15%). An independent blinded central adjudication committee will adjudicate all suspected primary end points.

Secondary Outcome Measures

Efficacy Outcome as a measure of major cardiovascular events
Secondary efficacy combined endpoint: death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, recurrent ischemia, TIA, or other arterial thrombotic event. We will also measure the individual outcomes all-cause mortality and need for rescue PCI, as well as individual components of the combined efficacy endpoint.
Safety Outcome as a measure of bleeding event
Secondary safety endpoints: Total bleeding (major and minor) according to PLATO, TIMI and BARC definitions, minor bleeding according to the TIMI definition and major bleeding as individual endpoint according to the PLATO definition. Others safety variables will include: dyspnea, arrhythmia, bradycardia and laboratory safety tests

Full Information

First Posted
October 27, 2014
Last Updated
February 12, 2019
Sponsor
Hospital do Coracao
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1. Study Identification

Unique Protocol Identification Number
NCT02298088
Brief Title
Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis
Acronym
TREAT
Official Title
Phase III, Randomized, International, Multicenter, Open Label, With Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With Acute Coronary Syndrome With ST Elevation Treated With Pharmacological Thrombolysis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis
Detailed Description
Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated with Pharmacological Thrombolysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Segment Elevation Myocardial Infarction, Thrombolysis in Myocardial Infarction Flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Blinded adjudication
Allocation
Randomized
Enrollment
3799 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor 180 mg
Arm Type
Active Comparator
Arm Description
Patients assigned to Ticagrelor will receive oral Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Patients will take the 300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months. For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 180 mg
Other Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months. For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.
Primary Outcome Measure Information:
Title
Safety Outcome as a measure of Time to TIMI-defined first major bleeding
Description
The primary safety endpoint is time to TIMI-defined and adjudicated first major bleeding event (including major life-threatening bleeding and other major bleeding). Bleeding TIMI Definition Major: Any intracranial hemorrhage (ICH)*, OR Clinically significant overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of ≥ 5 g/dL (or, when Hgb is not available, an absolute drop in hematocrit (Hct) of ≥ 15%). An independent blinded central adjudication committee will adjudicate all suspected primary end points.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Efficacy Outcome as a measure of major cardiovascular events
Description
Secondary efficacy combined endpoint: death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, recurrent ischemia, TIA, or other arterial thrombotic event. We will also measure the individual outcomes all-cause mortality and need for rescue PCI, as well as individual components of the combined efficacy endpoint.
Time Frame
12 months
Title
Safety Outcome as a measure of bleeding event
Description
Secondary safety endpoints: Total bleeding (major and minor) according to PLATO, TIMI and BARC definitions, minor bleeding according to the TIMI definition and major bleeding as individual endpoint according to the PLATO definition. Others safety variables will include: dyspnea, arrhythmia, bradycardia and laboratory safety tests
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of both sexes aged ≥ 18 years and < 75 years with ACS with ST segment elevation with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of > 10 minutes duration at rest, treated with pharmacological thrombolysis Fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours Patients with acute coronary syndrome with ST segment elevation will be included provided they present ST segment elevation at the J point in two contiguous leads in electrocardiogram with cut-points: > 0.1mV in all leads other than leads V2-V3, where the following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or >0.15 mV in women and at least 1 of the following criteria: Angina-like chest pain or ischemic equivalent chest pain; Abnormalities above the reference value for markers of myocardial necrosis (troponin and CK-MB). The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations. Exclusion Criteria: Any contraindication against the use of clopidogrel (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, history of intracranial hemorrhage) Need for oral anticoagulation therapy, Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine) Increased risk of bradycardia events Dialysis required Known clinically important thrombocytopenia Known clinically important anemia Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer) Participant in another investigational drug or device study within 30 d Pregnancy or lactation Any condition that increases the risk for noncompliance or being lost to follow-up Involvement in the planning or conduct of the study Previous enrollment or randomization in this study Contraindications to fibrinolytic therapy including: 15 Any prior intracranial hemorrhage Known structural cerebral vascular lesion (eg, Arterial Venous Malformation - AVM) Known malignant intracranial neoplasm (primary or metastatic) Ischemic stroke within 3 months Suspected aortic dissection Active bleeding or bleeding diathesis (excluding menses) Significant closed head trauma or facial trauma within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otavio Berwanger, MD,PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helio P Guimaraes, MD,PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leopoldo S Piegas, MD,PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Renato D Lopes, MD,PhD
Organizational Affiliation
Duke University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose C Nicolau, MD,PhD
Organizational Affiliation
Instituto do Coracao HC-FMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francisco A Fonseca, MD,PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose F Saraiva, MD,PhD
Organizational Affiliation
Hospital e Maternidade Celso Pierro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Tajer, MD,PhD
Organizational Affiliation
Investigación Independiente S.A.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephen Nicholls, MD,PhD
Organizational Affiliation
South Australian Health and Medical Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shaun Goodman, MD,PhD
Organizational Affiliation
Canadian Heart Research Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lixin Jiang, MD,PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Harvey White, MD,PhD
Organizational Affiliation
Auckland City Hospital - Auckland District Health Board
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Germán Malaga, MD,PhD
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oleg Averkov, MD,PhD
Organizational Affiliation
Clinical Hospital #15 Clinical Hospital #15 named after O.M.Filatov, Moscow, Russia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexander Parkhomenko, MD,PhD
Organizational Affiliation
Institute of Cardiology - Emergency Cardiology Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christopher Granger, MD,PhD
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Interzonal General de Agudos Dr, José Penna
City
Bahia Blanca
Country
Argentina
Facility Name
Hospital Alvarez
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Del Cruce Nestor Kishner
City
Florencio Varela
Country
Argentina
Facility Name
Hospital Español de La Plata
City
La Plata
Country
Argentina
Facility Name
Sanatorio Modelo de Quilmes
City
Quilmes
Country
Argentina
Facility Name
Hospital Zenón Santillan
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Flinders Medical Centre
City
Adelaide
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Cairns Hospital
City
Cairns
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Facility Name
Mildura Hospital
City
Mildura
Country
Australia
Facility Name
John Hunter Hospital
City
Newcastle
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Perth
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
Country
Australia
Facility Name
Townsville Hospital
City
Townsville
Country
Australia
Facility Name
Wollongong Hospital
City
Wollongong
Country
Australia
Facility Name
Hospital das Clínicas - UFMG
City
Belo Horizonte
Country
Brazil
Facility Name
Hospital Lifecenter
City
Belo Horizonte
Country
Brazil
Facility Name
Hospital Universitario Sao Jose
City
Belo Horizonte
Country
Brazil
Facility Name
Santa Case de Belo Horizonte
City
Belo Horizonte
Country
Brazil
Facility Name
Hospital de Base do Distrito Federal
City
Brasília
Country
Brazil
Facility Name
Instituto de Cardiologia do Distrito Federal
City
Brasília
Country
Brazil
Facility Name
Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP
City
Campinas
Country
Brazil
Facility Name
Hospital e Maternidade Celso Pierro
City
Campinas
Country
Brazil
Facility Name
Hospital e Clinica Sao Roque
City
Ipiau
Country
Brazil
Facility Name
Hospital e Pronto Socorro 28 de Agosto
City
Manaus
Country
Brazil
Facility Name
Hospital de Messejana
City
Messejana
Country
Brazil
Facility Name
Santa Casa de Montes Claros
City
Montes Claros
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
Country
Brazil
Facility Name
Hospital Pronto Socorro e Maternidade Santa Lucia
City
Pocos de Caldas
Country
Brazil
Facility Name
Instituto de Cardiologia - Fundação de Cardiologia (ICFUC)
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Agamenon Magalhaes
City
Recife
Country
Brazil
Facility Name
Hospital Municipal de Emergencia Albert Sabin
City
Sao Caetano do Sul
Country
Brazil
Facility Name
Santa Casa de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
Country
Brazil
Facility Name
Hospital do Coracao
City
Sao Paulo
ZIP/Postal Code
040005-000
Country
Brazil
Facility Name
Hospital do Mandaqui
City
Sao Paulo
Country
Brazil
Facility Name
Hospital Geral do Grajau / UNISA
City
Sao Paulo
Country
Brazil
Facility Name
Hospital Municipal do Campo Limpo
City
Sao Paulo
Country
Brazil
Facility Name
Hospital TotalCor
City
Sao Paulo
Country
Brazil
Facility Name
PreventSenior
City
Sao Paulo
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
Cardiolima
City
Teresina
Country
Brazil
Facility Name
Royal Alexandra Hospital
City
Edmonton
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
Country
Canada
Facility Name
University Hospital / London Health Sciences Centre - Interventional Cardiology
City
London
Country
Canada
Facility Name
Southlake Regional Health Centre - Interventional Cardiology
City
Newmarket
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
Country
Canada
Facility Name
Peterborough Regional Health Centre
City
Peterborough
Country
Canada
Facility Name
Inst Uni de Cardiologie et Pneumologie de Quebec
City
Quebec
Country
Canada
Facility Name
Regina General Hospital - Prairie Vascular Research Network (PVRN) - SETFAST Coordinating Centre (SCC)
City
Regina
Country
Canada
Facility Name
New Brunswick Heart Centre Research Initiative
City
Saint John
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre - Cardiac Cath Lab
City
Thunder Bay
Country
Canada
Facility Name
Centre Intégré Universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
City
Trois-Rivieres
Country
Canada
Facility Name
Victoria Heart Institute Foundation
City
Victoria,
Country
Canada
Facility Name
St. Mary's General Hospital
City
Waterloo
Country
Canada
Facility Name
Windsor Regional Hospital
City
Windsor
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
Country
Canada
Facility Name
Alxa League Central Hospital
City
Alashan
Country
China
Facility Name
Anshan Changda Hospital
City
Anshan
Country
China
Facility Name
Third affiliated hospital of Inner Mongolia medical university
City
Baotou
Country
China
Facility Name
Urad Front Banner People's Hospital
City
Bayan Nur
Country
China
Facility Name
The First Hospital of Fangshan District, Beijing
City
Beijing
Country
China
Facility Name
Benxi Jinshan Hospital
City
Benxi
Country
China
Facility Name
Binzhou City Center Hospital
City
Binzhou
Country
China
Facility Name
Changyuan County People's Hospital
City
Changyuan
Country
China
Facility Name
Chaoyang Second People's Hospital
City
Chaoyang
Country
China
Facility Name
Dengfeng People's Hospital
City
Dengfeng
Country
China
Facility Name
Dunhua Hospital
City
Dunhua
Country
China
Facility Name
Fushun Mining Bureau General Hospital
City
Fushun
Country
China
Facility Name
Gongyi People's Hospital
City
Gongyi
Country
China
Facility Name
Hulunbuir People's Hospital
City
Harbin
Country
China
Facility Name
Qi County People's Hospital
City
Hebi
Country
China
Facility Name
Heze Municipal Hospital
City
Heze
Country
China
Facility Name
Hunchun People's Hospital
City
Hunchun
Country
China
Facility Name
Wen Country People´s Hospital
City
Jiaozuo
Country
China
Facility Name
Laixi People's Hospital
City
Laixi
Country
China
Facility Name
The Second Hospital of Liaocheng
City
Liaocheng
Country
China
Facility Name
The Third People's Hospital of LiaoYang
City
Liaoyang
Country
China
Facility Name
Dongfeng County Hospital
City
Liaoyuan
Country
China
Facility Name
Houma People's Hospital
City
Linfen
Country
China
Facility Name
Lingbao First People's Hospital
City
Lingbao
Country
China
Facility Name
Ruyang People's Hospital
City
Luoyang
Country
China
Facility Name
Anhui Province Mengcheng County, People's Hospital
City
Mengcheng
Country
China
Facility Name
Puyang Zhongyuan Oil field General Hospital
City
Puyang
Country
China
Facility Name
Qinyang People's Hospital
City
Qinyang
Country
China
Facility Name
Sanmenxia Central Hospital
City
Sanmenxia
Country
China
Facility Name
Shangqiu Changzheng People's Hospital
City
Shangqiu
Country
China
Facility Name
Shenyang Sujiatun District Central Hospital
City
Shenyang
Country
China
Facility Name
Shenyang the Fourth Hospital of People
City
Shenyang
Country
China
Facility Name
Xinmin People's Hospital
City
Shenyang
Country
China
Facility Name
Jingxing County Hospital
City
Shijiazhuang
Country
China
Facility Name
Laoting Hospital
City
Tangshan
Country
China
Facility Name
Wuchuan People's Hospital
City
Wuchuan
Country
China
Facility Name
Wuhai People's Hospital
City
Wuhai
Country
China
Facility Name
Affiliated PuAi Hospital of Tongji Medical College
City
Wuhan
Country
China
Facility Name
Wuyishan Municipal Hospital
City
Wuyishan
Country
China
Facility Name
Qinghai Cardiovascular Hospital
City
Xining
Country
China
Facility Name
Feng County People's Hospita
City
Xuzhou
Country
China
Facility Name
Yongcheng People's Hospital
City
Yongcheng
Country
China
Facility Name
Jiang Hua Yao Autonomous County People's Hospital
City
Yongzhou
Country
China
Facility Name
The First People's Hospital of YueYang
City
Yueyang
Country
China
Facility Name
Zhangye People's Hospital
City
Zhangye
Country
China
Facility Name
Dancheng County People's Hospital
City
Zhoukou
Country
China
Facility Name
Huaiyang County People's Hospital
City
Zhoukou
Country
China
Facility Name
Foundation Cardiomet Cequin
City
Armenia
Country
Colombia
Facility Name
Centro de Diagnostico Cardiologico Ltda
City
Cartagena
Country
Colombia
Facility Name
Hawkes Bay Hospital
City
Hastings
Country
New Zealand
Facility Name
Nelson Hospital
City
Nelson
Country
New Zealand
Facility Name
Taranaki Hospital
City
New Plymouth
Country
New Zealand
Facility Name
Rotorua Hospital
City
Rotorua
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
Country
New Zealand
Facility Name
Thames Hospital
City
Thames
Country
New Zealand
Facility Name
Whangarei Base Hopsital
City
Whangarei
Country
New Zealand
Facility Name
Hospital Regional Lamabayeque
City
Chiclayo
Country
Peru
Facility Name
Clínica Internacional
City
Lima
Country
Peru
Facility Name
Clínica San Pablo
City
Lima
Country
Peru
Facility Name
Hospital Cayetano Heredia
City
Lima
Country
Peru
Facility Name
Hospital Hipólito Unanue
City
Lima
Country
Peru
Facility Name
Regional State Budget Healthcare Institution Altai Regional Cardiology Dispensary
City
Barnaul
Country
Russian Federation
Facility Name
State Healthcare Institution "Belgorod regional clinical hospital named after Prelate Ioasaf
City
Belgorod
Country
Russian Federation
Facility Name
State Budget Healthcare Institution "Chelyabinsk regional clinical hospital #3"
City
Chelyabinsk
Country
Russian Federation
Facility Name
State Budget Healthcare Institution Leningrad region Gatchina Clinical Inter-district Hospital
City
Gatchina
Country
Russian Federation
Facility Name
State Healthcare Institution Irkutsk regional clinical hospital
City
Irkutsk
Country
Russian Federation
Facility Name
Kirov Regional State Budget Healthcare Institution Kirov City clinical hospital #1
City
Kirov
Country
Russian Federation
Facility Name
Regional State Budget Healthcare Institution Krasnoyarsk Regional Clinical Hospital
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Municipal Healthcare Institution Lyubertsy regional Hospital #2
City
Lyubertsy
Country
Russian Federation
Facility Name
State Regional Budget Healthcare Institution Murmansk region Clinical Hospital named after P.A. Bayandin
City
Murmansk
Country
Russian Federation
Facility Name
State Budget Healthcare Institution Novosibirsk region City Clinical Hospital #34
City
Novosibirsk
Country
Russian Federation
Facility Name
Institution of the Russian academy of sciences Hospital of Pushchino Research Center of RAS
City
Pushchino
Country
Russian Federation
Facility Name
Municipal Budget Healthcare Institution Rostov-on-Don City Emergency Care Hospital
City
Rostov-on-Don
Country
Russian Federation
Facility Name
State Budget Healthcare Institution Ryazan region Regional Clinical Hospital
City
Ryazan
Country
Russian Federation
Facility Name
State Budget Educational Institution of Higher Professional Education "Smolensk State Medical University" Ministry of Healthcare of Russian Federation, clinical facility is State Budget Healthcare Institution "Smolensk regional clinical hospital"
City
Smolensk
Country
Russian Federation
Facility Name
Federal State Budget Science Institution "Science and Research Institute of Cardiology"
City
Tomsk
Country
Russian Federation
Facility Name
State Healthcare Institution of Tula Region "Tula regional clinical hospital
City
Tula
Country
Russian Federation
Facility Name
Tver Regional Clinical Hospital
City
Tver
Country
Russian Federation
Facility Name
State Budget Healthcare Institution Vladimir region City Hospital #4
City
Vladimir
Country
Russian Federation
Facility Name
Budget Healthcare Institution Voronezh region City Clinical Emergency Care Hospital #1
City
Voronezh
Country
Russian Federation
Facility Name
State Budget Healthcare Institution of Yaroslavl region "Regional clinical hospital"
City
Yaroslavl
Country
Russian Federation
Facility Name
Cherkasy Regional Cardiology Center, Department of Acute Heart Failure and Arrythmia
City
Cherkasy
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Department of Anestesiology and Intensive Care, SI"Ivano-Frankivsk National Medical University", Chair of Internal Medicine №2 and nurcering
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Municipal Healthcare Institution "Kharkiv City Clinical Hospital #8", Cardiology Department for MI patients N1, Kharkiv Medical Academy of Postgraduate Education
City
Kharkiv
Country
Ukraine
Facility Name
SI "National Institut of Therapy named after L.T. Malaya NAMS of Ukraine", Department of Acute Myocardial Infarction
City
Kharkiv
Country
Ukraine
Facility Name
Kiev Oleksandrivsk Clinical Hospital, department of Cardiology Reanimation, National Medical University named after O.O. Bogomolets, Chair of Internal Medicine №2
City
Kyiv
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #1, Department of Emergency Cardiology
City
Kyiv
Country
Ukraine
Facility Name
Kyiv Emergency Care Hospital, Infarction Department
City
Kyiv
Country
Ukraine
Facility Name
City Clinical Hospital # 1
City
Mykolaiv
Country
Ukraine
Facility Name
MI "City Clinical Hospital N3 named after prof. K.J. Alejnikovoi", department of intensice cardiology care unit
City
Odesa
Country
Ukraine
Facility Name
MI "Rivne Regional Clinical Hospital"
City
Rivne
Country
Ukraine
Facility Name
Sumy regional Cardiology Dispensary
City
Sumy
Country
Ukraine
Facility Name
MI "Regional Medical Center of Cardiovascular Diseases" of Zaporizhzhia Regional Council, Intensive Care Unit
City
Zaporizhzhya
Country
Ukraine
Facility Name
Municipal Institution " Central city clinical hospital N1", cardiology department for MI patients
City
Zhytomyr
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
35533724
Citation
Cantor WJ, Tan M, Berwanger O, Lavi S, White HD, Nicolau JC, Dehghani P, Tajer CD, Lopes RD, Moia DDF, Nicholls SJ, Parkhomenko A, Averkov O, Brass N, Lutchmedial S, Malaga G, Damiani LP, Piegas LS, Granger CB, Goodman SG. Morphine and clinical outcomes in patients with ST segment elevation myocardial infarction treated with fibrinolytic and antiplatelet therapy: Insights from the TREAT trial. Am Heart J. 2022 Sep;251:1-12. doi: 10.1016/j.ahj.2022.05.005. Epub 2022 May 6.
Results Reference
derived
PubMed Identifier
30898608
Citation
Berwanger O, Lopes RD, Moia DDF, Fonseca FA, Jiang L, Goodman SG, Nicholls SJ, Parkhomenko A, Averkov O, Tajer C, Malaga G, Saraiva JFK, Guimaraes HP, de Barros E Silva PGM, Damiani LP, Santos RHN, Paisani DM, Miranda TA, Valeis N, Piegas LS, Granger CB, White HD, Nicolau JC. Ticagrelor Versus Clopidogrel in Patients With STEMI Treated With Fibrinolysis: TREAT Trial. J Am Coll Cardiol. 2019 Jun 11;73(22):2819-2828. doi: 10.1016/j.jacc.2019.03.011. Epub 2019 Mar 18.
Results Reference
derived
PubMed Identifier
29525822
Citation
Berwanger O, Nicolau JC, Carvalho AC, Jiang L, Goodman SG, Nicholls SJ, Parkhomenko A, Averkov O, Tajer C, Malaga G, Saraiva JFK, Fonseca FA, De Luca FA, Guimaraes HP, de Barros E Silva PGM, Damiani LP, Paisani DM, Lasagno CMR, Candido CT, Valeis N, Moia DDF, Piegas LS, Granger CB, White HD, Lopes RD; TREAT Study Group. Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2018 May 1;3(5):391-399. doi: 10.1001/jamacardio.2018.0612. Erratum In: JAMA Cardiol. 2018 May 1;3(5):445.
Results Reference
derived

Learn more about this trial

Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis

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