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

February 12, 2019 updated by: Hospital do Coracao

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.

Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

3799

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bahia Blanca, Argentina
        • Hospital Interzonal General de Agudos Dr, José Penna
      • Ciudad Autonoma de Buenos Aires, Argentina
        • Hospital Alvarez
      • Florencio Varela, Argentina
        • Hospital Del Cruce Nestor Kishner
      • La Plata, Argentina
        • Hospital Español de La Plata
      • Quilmes, Argentina
        • Sanatorio Modelo de Quilmes
      • San Miguel de Tucuman, Argentina
        • Hospital Zenón Santillan
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Adelaide, Australia
        • Flinders Medical Centre
      • Cairns, Australia
        • Cairns Hospital
      • Melbourne, Australia
        • The Alfred Hospital
      • Mildura, Australia
        • Mildura Hospital
      • Newcastle, Australia
        • John Hunter Hospital
      • Perth, Australia
        • Fiona Stanley Hospital
      • Sydney, Australia
        • Liverpool Hospital
      • Townsville, Australia
        • Townsville Hospital
      • Wollongong, Australia
        • Wollongong Hospital
      • Belo Horizonte, Brazil
        • Hospital Universitario Sao Jose
      • Belo Horizonte, Brazil
        • Hospital Lifecenter
      • Belo Horizonte, Brazil
        • Hospital das Clinicas - UFMG
      • Belo Horizonte, Brazil
        • Santa Case de Belo Horizonte
      • Brasília, Brazil
        • Instituto de Cardiologia do Distrito Federal
      • Brasília, Brazil
        • Hospital de Base do Distrito Federal
      • Campinas, Brazil
        • Hospital de Clínicas da Universidade Estadual de Campinas - Unicamp
      • Campinas, Brazil
        • Hospital e Maternidade Celso Pierro
      • Ipiau, Brazil
        • Hospital e Clínica São Roque
      • Manaus, Brazil
        • Hospital e Pronto Socorro 28 de Agosto
      • Messejana, Brazil
        • Hospital de Messejana
      • Montes Claros, Brazil
        • Santa Casa de Montes Claros
      • Passo Fundo, Brazil
        • Hospital Sao Vicente de Paulo
      • Pocos de Caldas, Brazil
        • Hospital Pronto Socorro e Maternidade Santa Lucia
      • Porto Alegre, Brazil
        • Instituto de Cardiologia - Fundação de Cardiologia (ICFUC)
      • Recife, Brazil
        • Hospital Agamenon Magalhães
      • Sao Caetano do Sul, Brazil
        • Hospital Municipal de Emergencia Albert Sabin
      • Sao Jose do Rio Preto, Brazil
        • Santa Casa de Sao Jose do Rio Preto
      • Sao Paulo, Brazil, 040005-000
        • Hospital do Coracao
      • Sao Paulo, Brazil
        • Hospital do Mandaqui
      • Sao Paulo, Brazil
        • Hospital Geral do Grajau / UNISA
      • Sao Paulo, Brazil
        • Hospital Municipal do Campo Limpo
      • Sao Paulo, Brazil
        • Hospital TotalCor
      • Sao Paulo, Brazil
        • PreventSenior
      • Sao Paulo, Brazil
        • Universidade Federal de Sao Paulo
      • Teresina, Brazil
        • Cardiolima
      • Edmonton, Canada
        • Royal Alexandra Hospital
      • Edmonton, Canada
        • University Of Alberta Hospital
      • Halifax, Canada
        • Queen Elizabeth II Health Sciences Centre
      • London, Canada
        • University Hospital / London Health Sciences Centre - Interventional Cardiology
      • Newmarket, Canada
        • Southlake Regional Health Centre - Interventional Cardiology
      • Ottawa, Canada
        • University of Ottawa Heart Institute
      • Peterborough, Canada
        • Peterborough Regional Health Centre
      • Quebec, Canada
        • Inst Uni de Cardiologie et Pneumologie de Quebec
      • Regina, Canada
        • Regina General Hospital - Prairie Vascular Research Network (PVRN) - SETFAST Coordinating Centre (SCC)
      • Saint John, Canada
        • New Brunswick Heart Centre Research Initiative
      • Sherbrooke, Canada
        • Centre hospitalier universitaire de Sherbrooke
      • Thunder Bay, Canada
        • Thunder Bay Regional Health Sciences Centre - Cardiac Cath Lab
      • Trois-Rivieres, Canada
        • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec
      • Victoria,, Canada
        • Victoria Heart Institute Foundation
      • Waterloo, Canada
        • St. Mary's general Hospital
      • Windsor, Canada
        • Windsor Regional Hospital
      • Winnipeg, Canada
        • St. Boniface General Hospital
      • Alashan, China
        • Alxa League Central Hospital
      • Anshan, China
        • Anshan Changda Hospital
      • Baotou, China
        • Third affiliated hospital of Inner Mongolia medical university
      • Bayan Nur, China
        • Urad Front Banner People's Hospital
      • Beijing, China
        • The First Hospital of Fangshan District, Beijing
      • Benxi, China
        • Benxi Jinshan Hospital
      • Binzhou, China
        • Binzhou City Center Hospital
      • Changyuan, China
        • Changyuan County People's Hospital
      • Chaoyang, China
        • Chaoyang Second People's Hospital
      • Dengfeng, China
        • Dengfeng People's Hospital
      • Dunhua, China
        • Dunhua Hospital
      • Fushun, China
        • Fushun Mining Bureau General Hospital
      • Gongyi, China
        • Gongyi People's Hospital
      • Harbin, China
        • Hulunbuir People's Hospital
      • Hebi, China
        • Qi County People's Hospital
      • Heze, China
        • Heze Municipal Hospital
      • Hunchun, China
        • Hunchun people's hospital
      • Jiaozuo, China
        • Wen Country People´s Hospital
      • Laixi, China
        • Laixi People's Hospital
      • Liaocheng, China
        • The Second Hospital of Liaocheng
      • Liaoyang, China
        • The Third People's Hospital of LiaoYang
      • Liaoyuan, China
        • Dongfeng County Hospital
      • Linfen, China
        • Houma people's hospital
      • Lingbao, China
        • Lingbao First People's Hospital
      • Luoyang, China
        • Ruyang People's Hospital
      • Mengcheng, China
        • Anhui Province Mengcheng County, People's Hospital
      • Puyang, China
        • Puyang Zhongyuan Oil field General Hospital
      • Qinyang, China
        • Qinyang People's Hospital
      • Sanmenxia, China
        • Sanmenxia Central Hospital
      • Shangqiu, China
        • Shangqiu Changzheng People's Hospital
      • Shenyang, China
        • Shenyang Sujiatun District Central Hospital
      • Shenyang, China
        • Shenyang the Fourth Hospital of People
      • Shenyang, China
        • Xinmin People's Hospital
      • Shijiazhuang, China
        • Jingxing County Hospital
      • Tangshan, China
        • Laoting Hospital
      • Wuchuan, China
        • Wuchuan People's Hospital
      • Wuhai, China
        • Wuhai People's Hospital
      • Wuhan, China
        • Affiliated PuAi Hospital of Tongji Medical College
      • Wuyishan, China
        • Wuyishan Municipal Hospital
      • Xining, China
        • Qinghai Cardiovascular Hospital
      • Xuzhou, China
        • Feng County People's Hospita
      • Yongcheng, China
        • Yongcheng People's Hospital
      • Yongzhou, China
        • Jiang Hua Yao Autonomous County People's Hospital
      • Yueyang, China
        • The First People's Hospital of Yueyang
      • Zhangye, China
        • Zhangye People's Hospital
      • Zhoukou, China
        • Dancheng County People's Hospital
      • Zhoukou, China
        • Huaiyang County People's Hospital
      • Armenia, Colombia
        • Foundation Cardiomet Cequin
      • Cartagena, Colombia
        • Centro de Diagnostico Cardiologico Ltda
      • Hastings, New Zealand
        • Hawkes Bay Hospital
      • Nelson, New Zealand
        • Nelson Hospital
      • New Plymouth, New Zealand
        • Taranaki Hospital
      • Rotorua, New Zealand
        • Rotorua Hospital
      • Tauranga, New Zealand
        • Tauranga Hospital
      • Thames, New Zealand
        • Thames Hospital
      • Whangarei, New Zealand
        • Whangarei Base Hopsital
      • Chiclayo, Peru
        • Hospital Regional Lamabayeque
      • Lima, Peru
        • Hospital Cayetano Heredia
      • Lima, Peru
        • Clinica Internacional
      • Lima, Peru
        • Clinica San Pablo
      • Lima, Peru
        • Hospital Hipolito Unanue
      • Barnaul, Russian Federation
        • Regional State Budget Healthcare Institution Altai Regional Cardiology Dispensary
      • Belgorod, Russian Federation
        • State Healthcare Institution "Belgorod regional clinical hospital named after Prelate Ioasaf
      • Chelyabinsk, Russian Federation
        • State Budget Healthcare Institution "Chelyabinsk regional clinical hospital #3"
      • Gatchina, Russian Federation
        • State Budget Healthcare Institution Leningrad region Gatchina Clinical Inter-district Hospital
      • Irkutsk, Russian Federation
        • State Healthcare Institution Irkutsk regional clinical hospital
      • Kirov, Russian Federation
        • Kirov Regional State Budget Healthcare Institution Kirov City clinical hospital #1
      • Krasnoyarsk, Russian Federation
        • Regional State Budget Healthcare Institution Krasnoyarsk Regional Clinical Hospital
      • Lyubertsy, Russian Federation
        • Municipal Healthcare Institution Lyubertsy regional Hospital #2
      • Murmansk, Russian Federation
        • State Regional Budget Healthcare Institution Murmansk region Clinical Hospital named after P.A. Bayandin
      • Novosibirsk, Russian Federation
        • State Budget Healthcare Institution Novosibirsk region City Clinical Hospital #34
      • Pushchino, Russian Federation
        • Institution of the Russian academy of sciences Hospital of Pushchino Research Center of RAS
      • Rostov-on-Don, Russian Federation
        • Municipal Budget Healthcare Institution Rostov-on-Don City Emergency Care Hospital
      • Ryazan, Russian Federation
        • State Budget Healthcare Institution Ryazan region Regional Clinical Hospital
      • Smolensk, Russian Federation
        • 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"
      • Tomsk, Russian Federation
        • Federal State Budget Science Institution "Science and Research Institute of Cardiology"
      • Tula, Russian Federation
        • State Healthcare Institution of Tula Region "Tula regional clinical hospital
      • Tver, Russian Federation
        • Tver Regional Clinical Hospital
      • Vladimir, Russian Federation
        • State Budget Healthcare Institution Vladimir region City Hospital #4
      • Voronezh, Russian Federation
        • Budget Healthcare Institution Voronezh region City Clinical Emergency Care Hospital #1
      • Yaroslavl, Russian Federation
        • State Budget Healthcare Institution of Yaroslavl region "Regional clinical hospital"
      • Cherkasy, Ukraine
        • Cherkasy Regional Cardiology Center, Department of Acute Heart Failure and Arrythmia
      • Ivano-Frankivsk, Ukraine
        • 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
      • Kharkiv, Ukraine
        • Municipal Healthcare Institution "Kharkiv City Clinical Hospital #8", Cardiology Department for MI patients N1, Kharkiv Medical Academy of Postgraduate Education
      • Kharkiv, Ukraine
        • SI "National Institut of Therapy named after L.T. Malaya NAMS of Ukraine", Department of Acute Myocardial Infarction
      • Kyiv, Ukraine
        • Kiev Oleksandrivsk Clinical Hospital, department of Cardiology Reanimation, National Medical University named after O.O. Bogomolets, Chair of Internal Medicine №2
      • Kyiv, Ukraine
        • Kyiv City Clinical Hospital #1, Department of Emergency Cardiology
      • Kyiv, Ukraine
        • Kyiv Emergency Care Hospital, Infarction Department
      • Mykolaiv, Ukraine
        • City Clinical Hospital # 1
      • Odesa, Ukraine
        • MI "City Clinical Hospital N3 named after prof. K.J. Alejnikovoi", department of intensice cardiology care unit
      • Rivne, Ukraine
        • MI "Rivne Regional Clinical Hospital"
      • Sumy, Ukraine
        • Sumy regional Cardiology Dispensary
      • Zaporizhzhya, Ukraine
        • MI "Regional Medical Center of Cardiovascular Diseases" of Zaporizhzhia Regional Council, Intensive Care Unit
      • Zhytomyr, Ukraine
        • Municipal Institution " Central city clinical hospital N1", cardiology department for MI patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ticagrelor 180 mg
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.
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.
Other Names:
  • Ticagrelor
Active Comparator: Clopidogrel

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Outcome as a measure of Time to TIMI-defined first major bleeding
Time Frame: 30 days

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.

30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Outcome as a measure of major cardiovascular events
Time Frame: 12 months

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.

12 months
Safety Outcome as a measure of bleeding event
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Otavio Berwanger, MD,PhD, Hospital do Coracao
  • Study Chair: Helio P Guimaraes, MD,PhD, Hospital do Coracao
  • Study Chair: Leopoldo S Piegas, MD,PhD, Hospital do Coracao
  • Study Chair: Renato D Lopes, MD,PhD, Duke University
  • Study Chair: Jose C Nicolau, MD,PhD, Instituto do Coracao HC-FMUSP
  • Study Chair: Francisco A Fonseca, MD,PhD, Universidade Federal de Sao Paulo
  • Study Chair: Jose F Saraiva, MD,PhD, Hospital e Maternidade Celso Pierro
  • Study Chair: Carlos Tajer, MD,PhD, Investigación Independiente S.A.
  • Study Chair: Stephen Nicholls, MD,PhD, South Australian Health and Medical Research Institute
  • Study Chair: Shaun Goodman, MD,PhD, Canadian Heart Research Centre
  • Study Chair: Lixin Jiang, MD,PhD, Fuwai Hospital
  • Study Chair: Harvey White, MD,PhD, Auckland City Hospital - Auckland District Health Board
  • Study Chair: Germán Malaga, MD,PhD, Universidad Peruana Cayetano Heredia
  • Study Chair: Oleg Averkov, MD,PhD, Clinical Hospital #15 Clinical Hospital #15 named after O.M.Filatov, Moscow, Russia
  • Study Chair: Alexander Parkhomenko, MD,PhD, Institute of Cardiology - Emergency Cardiology Department
  • Study Chair: Christopher Granger, MD,PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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