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Acute ST Segment Elevation Myocardial InfarctionPhase 3TREATNCT02298088

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

A Phase 3 study testing Ticagrelor 180 mg and Clopidogrel in people with Acute ST Segment Elevation Myocardial Infarction and Thrombolysis in Myocardial Infarction Flow, run by Hospital do Coracao at 153 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Ticagrelor 180 mg and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,799 participants
Where
153 sitesin 10 countries
Study dates
Aug 2015to Jan 2019
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

153 sites in 10 countries.

153 sites in 10 countries

China47 sites

  • Alxa League Central Hospital

    Alashan

  • Anshan Changda Hospital

    Anshan

  • Third affiliated hospital of Inner Mongolia medical university

    Baotou

  • Urad Front Banner People's Hospital

    Bayan Nur

  • The First Hospital of Fangshan District, Beijing

    Beijing

  • Benxi Jinshan Hospital

    Benxi

  • Binzhou City Center Hospital

    Binzhou

  • Changyuan County People's Hospital

    Changyuan

  • Chaoyang Second People's Hospital

    Chaoyang

  • Dengfeng People's Hospital

    Dengfeng

  • Dunhua Hospital

    Dunhua

  • Fushun Mining Bureau General Hospital

    Fushun

  • Gongyi People's Hospital

    Gongyi

  • Hulunbuir People's Hospital

    Harbin

  • Qi County People's Hospital

    Hebi

  • Heze Municipal Hospital

    Heze

  • Hunchun People's Hospital

    Hunchun

  • Wen Country People´s Hospital

    Jiaozuo

  • Laixi People's Hospital

    Laixi

  • The Second Hospital of Liaocheng

    Liaocheng

  • The Third People's Hospital of LiaoYang

    Liaoyang

  • Dongfeng County Hospital

    Liaoyuan

  • Houma People's Hospital

    Linfen

  • Lingbao First People's Hospital

    Lingbao

  • Ruyang People's Hospital

    Luoyang

  • Anhui Province Mengcheng County, People's Hospital

    Mengcheng

  • Puyang Zhongyuan Oil field General Hospital

    Pujiang

  • Qinyang People's Hospital

    Qinyang

  • Sanmenxia Central Hospital

    Sanmenxia

  • Shangqiu Changzheng People's Hospital

    Shangqiu

  • Shenyang Sujiatun District Central Hospital

    Shenyang

  • Shenyang the Fourth Hospital of People

    Shenyang

  • Xinmin People's Hospital

    Shenyang

  • Jingxing County Hospital

    Shijiazhuang

  • Laoting Hospital

    Tangshan

  • Wuchuan People's Hospital

    Wuchuan

  • Wuhai People's Hospital

    Wuhai

  • Affiliated PuAi Hospital of Tongji Medical College

    Wuhan

  • Wuyishan Municipal Hospital

    Wuyishan

  • Qinghai Cardiovascular Hospital

    Xining

  • Feng County People's Hospita

    Xuzhou

  • Yongcheng People's Hospital

    Yongcheng

  • Jiang Hua Yao Autonomous County People's Hospital

    Yongzhou

  • The First People's Hospital of YueYang

    Yueyang

  • Zhangye People's Hospital

    Zhangye

  • Dancheng County People's Hospital

    Zhoukou

  • Huaiyang County People's Hospital

    Zhoukou

Other trials in China

Brazil26 sites

  • Hospital das Clínicas - UFMG

    Belo Horizonte

  • Hospital Lifecenter

    Belo Horizonte

  • Hospital Universitario Sao Jose

    Belo Horizonte

  • Santa Case de Belo Horizonte

    Belo Horizonte

  • Hospital de Base do Distrito Federal

    Brasília

  • Instituto de Cardiologia do Distrito Federal

    Brasília

  • Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP

    Campinas

  • Hospital e Maternidade Celso Pierro

    Campinas

  • Hospital e Clinica Sao Roque

    Ipiaú

  • Hospital e Pronto Socorro 28 de Agosto

    Manaus

  • Hospital de Messejana

    Messejana

  • Santa Casa de Montes Claros

    Montes Claros

  • Hospital Sao Vicente de Paulo

    Passo Fundo

  • Hospital Pronto Socorro e Maternidade Santa Lucia

    Poços de Caldas

  • Instituto de Cardiologia - Fundação de Cardiologia (ICFUC)

    Porto Alegre

  • Hospital Agamenon Magalhaes

    Recife

  • Hospital Municipal de Emergencia Albert Sabin

    São Caetano do Sul

  • Santa Casa de Sao Jose do Rio Preto

    São José do Rio Preto

  • Hospital do Coracao

    São Paulo, 040005-000

  • Hospital do Mandaqui

    São Paulo

  • Hospital Geral do Grajau / UNISA

    São Paulo

  • Hospital Municipal do Campo Limpo

    São Paulo

  • Hospital TotalCor

    São Paulo

  • PreventSenior

    São Paulo

  • Universidade Federal de Sao Paulo

    São Paulo

  • Cardiolima

    Teresina

Other trials in Brazil

Russia20 sites

  • Regional State Budget Healthcare Institution Altai Regional Cardiology Dispensary

    Barnaul

  • State Healthcare Institution "Belgorod regional clinical hospital named after Prelate Ioasaf

    Belgorod

  • State Budget Healthcare Institution "Chelyabinsk regional clinical hospital #3"

    Chelyabinsk

  • State Budget Healthcare Institution Leningrad region Gatchina Clinical Inter-district Hospital

    Gatchina

  • State Healthcare Institution Irkutsk regional clinical hospital

    Irkutsk

  • Kirov Regional State Budget Healthcare Institution Kirov City clinical hospital #1

    Kirov

  • Regional State Budget Healthcare Institution Krasnoyarsk Regional Clinical Hospital

    Krasnoyarsk

  • Municipal Healthcare Institution Lyubertsy regional Hospital #2

    Lyubertsy

  • State Regional Budget Healthcare Institution Murmansk region Clinical Hospital named after P.A. Bayandin

    Murmansk

  • State Budget Healthcare Institution Novosibirsk region City Clinical Hospital #34

    Novosibirsk

  • Institution of the Russian academy of sciences Hospital of Pushchino Research Center of RAS

    Pushchino

  • Municipal Budget Healthcare Institution Rostov-on-Don City Emergency Care Hospital

    Rostov-on-Don

  • State Budget Healthcare Institution Ryazan region Regional Clinical Hospital

    Ryazan

  • 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"

    Smolensk

  • Federal State Budget Science Institution "Science and Research Institute of Cardiology"

    Tomsk

  • State Healthcare Institution of Tula Region "Tula regional clinical hospital

    Tula

  • Tver Regional Clinical Hospital

    Tver'

  • State Budget Healthcare Institution Vladimir region City Hospital #4

    Vladimir

  • Budget Healthcare Institution Voronezh region City Clinical Emergency Care Hospital #1

    Voronezh

  • State Budget Healthcare Institution of Yaroslavl region "Regional clinical hospital"

    Yaroslavl

Other trials in Russia

Canada17 sites

  • Royal Alexandra Hospital

    Edmonton

  • University of Alberta Hospital

    Edmonton

  • Queen Elizabeth II Health Sciences Centre

    Halifax

  • University Hospital / London Health Sciences Centre - Interventional Cardiology

    London

  • Southlake Regional Health Centre - Interventional Cardiology

    Newmarket

  • University of Ottawa Heart Institute

    Ottawa

  • Peterborough Regional Health Centre

    Peterborough

  • Inst Uni de Cardiologie et Pneumologie de Quebec

    Québec

  • Regina General Hospital - Prairie Vascular Research Network (PVRN) - SETFAST Coordinating Centre (SCC)

    Regina

  • New Brunswick Heart Centre Research Initiative

    Saint John

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke

  • Thunder Bay Regional Health Sciences Centre - Cardiac Cath Lab

    Thunder Bay

  • Centre Intégré Universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

    Trois-Rivières

  • Victoria Heart Institute Foundation

    Victoria

  • St. Mary's General Hospital

    Waterloo

  • Windsor Regional Hospital

    Windsor

  • St. Boniface General Hospital

    Winnipeg

Other trials in Canada

Ukraine13 sites

  • Cherkasy Regional Cardiology Center, Department of Acute Heart Failure and Arrythmia

    Cherkasy

  • 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

    Ivano-Frankivsk

  • Municipal Healthcare Institution "Kharkiv City Clinical Hospital #8", Cardiology Department for MI patients N1, Kharkiv Medical Academy of Postgraduate Education

    Kharkiv

  • SI "National Institut of Therapy named after L.T. Malaya NAMS of Ukraine", Department of Acute Myocardial Infarction

    Kharkiv

  • Kiev Oleksandrivsk Clinical Hospital, department of Cardiology Reanimation, National Medical University named after O.O. Bogomolets, Chair of Internal Medicine №2

    Kyiv

  • Kyiv City Clinical Hospital #1, Department of Emergency Cardiology

    Kyiv

  • Kyiv Emergency Care Hospital, Infarction Department

    Kyiv

  • City Clinical Hospital # 1

    Mykolaiv

  • MI "City Clinical Hospital N3 named after prof. K.J. Alejnikovoi", department of intensice cardiology care unit

    Odesa

  • MI "Rivne Regional Clinical Hospital"

    Rivne

  • Sumy regional Cardiology Dispensary

    Sumy

  • MI "Regional Medical Center of Cardiovascular Diseases" of Zaporizhzhia Regional Council, Intensive Care Unit

    Zaporizhzhya

  • Municipal Institution " Central city clinical hospital N1", cardiology department for MI patients

    Zhytomyr

Other trials in Ukraine

Australia10 sites

  • Flinders Medical Centre

    Adelaide

  • Royal Adelaide Hospital

    Adelaide

  • Cairns Hospital

    Cairns

  • The Alfred Hospital

    Melbourne

  • Mildura Hospital

    Mildura

  • John Hunter Hospital

    Newcastle

  • Fiona Stanley Hospital

    Perth

  • Liverpool Hospital

    Sydney

  • Townsville Hospital

    Townsville

  • Wollongong Hospital

    Wollongong

Other trials in Australia

New Zealand7 sites

  • Hawkes Bay Hospital

    Hastings

  • Nelson Hospital

    Nelson

  • Taranaki Hospital

    New Plymouth

  • Rotorua Hospital

    Rotorua

  • Tauranga Hospital

    Tauranga

  • Thames Hospital

    Thames

  • Whangarei Base Hopsital

    Whangarei

Other trials in New Zealand

Argentina6 sites

  • Hospital Interzonal General de Agudos Dr, José Penna

    Bahía Blanca

  • Hospital Alvarez

    Buenos Aires

  • Hospital Español de La Plata

    La Plata

  • Sanatorio Modelo de Quilmes

    Quilmes

  • Hospital Del Cruce Nestor Kishner

    San Juan Bautista

  • Hospital Zenón Santillan

    San Miguel de Tucumán

Other trials in Argentina

Peru5 sites

  • Hospital Regional Lamabayeque

    Chiclayo

  • Clínica Internacional

    Lima

  • Clínica San Pablo

    Lima

  • Hospital Cayetano Heredia

    Lima

  • Hospital Hipólito Unanue

    Lima

Other trials in Peru

Colombia2 sites

  • Foundation Cardiomet Cequin

    Armenia

  • Centro de Diagnostico Cardiologico Ltda

    Cartagena

Other trials in Colombia

About this study

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.

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

Read the 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.

Being tested
Ticagrelor 180 mg, Clopidogrel
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

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

  • Ticagrelor 180 mgDrug

    Also called Ticagrelor

    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.

  • ClopidogrelDrug

    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.

Study groups in NCT02298088
Study groupRoleWhat they receive
Ticagrelor 180 mgActive comparatorPatients 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.
Receives: Drug: Ticagrelor 180 mg
ClopidogrelActive comparatorPatients 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.
Receives: Drug: Clopidogrel

What is being measured

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

  1. 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.

    Measured: 30 days

Secondary outcomes (2)

  1. 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.

    Measured: 12 months

  2. 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

    Measured: 12 months

Timeline

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

  1. First posted21 Nov 2014 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2017
  4. Study completionJan 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02298088
Sponsor's protocol ID
TREAT01
Acronym
TREAT
Status last verified
Feb 2019
First submitted
27 Oct 2014
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35533724

  • 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.

    PubMed 30898608

  • 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.

    PubMed 29525822

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor 180 mg and Clopidogrel in people with Acute ST Segment Elevation Myocardial Infarction and Thrombolysis in Myocardial Infarction Flow, run by Hospital do Coracao at 153 sites in 10 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 6 inclusion and 21 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in China, Brazil, Russia, Canada, Ukraine and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcome as a measure of Time to TIMI-defined first major bleeding (time frame: 30 days). 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 NCT02298088, which also lists 3 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 Feb 2019.

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