Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis
NCT ID: NCT02298088
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3799 participants
INTERVENTIONAL
2015-08-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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.
Clopidogrel
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.
Interventions
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Ticagrelor 180 mg
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.
Clopidogrel
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hospital do Coracao
OTHER
Responsible Party
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Principal Investigators
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Otavio Berwanger, MD,PhD
Role: STUDY_CHAIR
Hospital do Coracao
Helio P Guimaraes, MD,PhD
Role: STUDY_CHAIR
Hospital do Coracao
Leopoldo S Piegas, MD,PhD
Role: STUDY_CHAIR
Hospital do Coracao
Renato D Lopes, MD,PhD
Role: STUDY_CHAIR
Duke University
Jose C Nicolau, MD,PhD
Role: STUDY_CHAIR
Instituto do Coracao HC-FMUSP
Francisco A Fonseca, MD,PhD
Role: STUDY_CHAIR
Universidade Federal de São Paulo
Jose F Saraiva, MD,PhD
Role: STUDY_CHAIR
Hospital e Maternidade Celso Pierro
Carlos Tajer, MD,PhD
Role: STUDY_CHAIR
Investigación Independiente S.A.
Stephen Nicholls, MD,PhD
Role: STUDY_CHAIR
South Australian Health and Medical Research Institute
Shaun Goodman, MD,PhD
Role: STUDY_CHAIR
Canadian Heart Research Centre
Lixin Jiang, MD,PhD
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Harvey White, MD,PhD
Role: STUDY_CHAIR
Auckland City Hospital - Auckland District Health Board
Germán Malaga, MD,PhD
Role: STUDY_CHAIR
Universidad Peruana Cayetano Heredia
Oleg Averkov, MD,PhD
Role: STUDY_CHAIR
Clinical Hospital #15 Clinical Hospital #15 named after O.M.Filatov, Moscow, Russia
Alexander Parkhomenko, MD,PhD
Role: STUDY_CHAIR
Institute of Cardiology - Emergency Cardiology Department
Christopher Granger, MD,PhD
Role: STUDY_CHAIR
Duke University
Locations
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Hospital Interzonal General de Agudos Dr, José Penna
Bahía Blanca, , Argentina
Hospital Alvarez
Buenos Aires, , Argentina
Hospital Español de La Plata
La Plata, , Argentina
Sanatorio Modelo de Quilmes
Quilmes, , Argentina
Hospital Del Cruce Nestor Kishner
San Juan Bautista, , Argentina
Hospital Zenón Santillan
San Miguel de Tucumán, , Argentina
Flinders Medical Centre
Adelaide, , Australia
Royal Adelaide Hospital
Adelaide, , Australia
Cairns Hospital
Cairns, , Australia
The Alfred Hospital
Melbourne, , Australia
Mildura Hospital
Mildura, , Australia
John Hunter Hospital
Newcastle, , Australia
Fiona Stanley Hospital
Perth, , Australia
Liverpool Hospital
Sydney, , Australia
Townsville Hospital
Townsville, , Australia
Wollongong Hospital
Wollongong, , Australia
Hospital das Clínicas - UFMG
Belo Horizonte, , Brazil
Hospital Lifecenter
Belo Horizonte, , Brazil
Hospital Universitario Sao Jose
Belo Horizonte, , Brazil
Santa Case de Belo Horizonte
Belo Horizonte, , Brazil
Hospital de Base do Distrito Federal
Brasília, , Brazil
Instituto de Cardiologia do Distrito Federal
Brasília, , Brazil
Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP
Campinas, , Brazil
Hospital e Maternidade Celso Pierro
Campinas, , Brazil
Hospital e Clinica Sao Roque
Ipiaú, , Brazil
Hospital e Pronto Socorro 28 de Agosto
Manaus, , Brazil
Hospital de Messejana
Messejana, , Brazil
Santa Casa de Montes Claros
Montes Claros, , Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, , Brazil
Hospital Pronto Socorro e Maternidade Santa Lucia
Poços de Caldas, , Brazil
Instituto de Cardiologia - Fundação de Cardiologia (ICFUC)
Porto Alegre, , Brazil
Hospital Agamenon Magalhaes
Recife, , Brazil
Hospital Municipal de Emergencia Albert Sabin
São Caetano do Sul, , Brazil
Santa Casa de Sao Jose do Rio Preto
São José do Rio Preto, , Brazil
Hospital do Coracao
São Paulo, , Brazil
Hospital do Mandaqui
São Paulo, , Brazil
Hospital Geral do Grajau / UNISA
São Paulo, , Brazil
Hospital Municipal do Campo Limpo
São Paulo, , Brazil
Hospital TotalCor
São Paulo, , Brazil
PreventSenior
São Paulo, , Brazil
Universidade Federal de Sao Paulo
São Paulo, , Brazil
Cardiolima
Teresina, , Brazil
Royal Alexandra Hospital
Edmonton, , Canada
University of Alberta Hospital
Edmonton, , Canada
Queen Elizabeth II Health Sciences Centre
Halifax, , Canada
University Hospital / London Health Sciences Centre - Interventional Cardiology
London, , Canada
Southlake Regional Health Centre - Interventional Cardiology
Newmarket, , Canada
University of Ottawa Heart Institute
Ottawa, , Canada
Peterborough Regional Health Centre
Peterborough, , Canada
Inst Uni de Cardiologie et Pneumologie de Quebec
Québec, , Canada
Regina General Hospital - Prairie Vascular Research Network (PVRN) - SETFAST Coordinating Centre (SCC)
Regina, , Canada
New Brunswick Heart Centre Research Initiative
Saint John, , Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, , Canada
Thunder Bay Regional Health Sciences Centre - Cardiac Cath Lab
Thunder Bay, , Canada
Centre Intégré Universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
Trois-Rivières, , Canada
Victoria Heart Institute Foundation
Victoria, , Canada
St. Mary's General Hospital
Waterloo, , Canada
Windsor Regional Hospital
Windsor, , Canada
St. Boniface General Hospital
Winnipeg, , Canada
Alxa League Central Hospital
Alashan, , China
Anshan Changda Hospital
Anshan, , China
Third affiliated hospital of Inner Mongolia medical university
Baotou, , China
Urad Front Banner People's Hospital
Bayan Nur, , China
The First Hospital of Fangshan District, Beijing
Beijing, , China
Benxi Jinshan Hospital
Benxi, , China
Binzhou City Center Hospital
Binzhou, , China
Changyuan County People's Hospital
Changyuan, , China
Chaoyang Second People's Hospital
Chaoyang, , China
Dengfeng People's Hospital
Dengfeng, , China
Dunhua Hospital
Dunhua, , China
Fushun Mining Bureau General Hospital
Fushun, , China
Gongyi People's Hospital
Gongyi, , China
Hulunbuir People's Hospital
Harbin, , China
Qi County People's Hospital
Hebi, , China
Heze Municipal Hospital
Heze, , China
Hunchun People's Hospital
Hunchun, , China
Wen Country People´s Hospital
Jiaozuo, , China
Laixi People's Hospital
Laixi, , China
The Second Hospital of Liaocheng
Liaocheng, , China
The Third People's Hospital of LiaoYang
Liaoyang, , China
Dongfeng County Hospital
Liaoyuan, , China
Houma People's Hospital
Linfen, , China
Lingbao First People's Hospital
Lingbao, , China
Ruyang People's Hospital
Luoyang, , China
Anhui Province Mengcheng County, People's Hospital
Mengcheng, , China
Puyang Zhongyuan Oil field General Hospital
Pujiang, , China
Qinyang People's Hospital
Qinyang, , China
Sanmenxia Central Hospital
Sanmenxia, , China
Shangqiu Changzheng People's Hospital
Shangqiu, , China
Shenyang Sujiatun District Central Hospital
Shenyang, , China
Shenyang the Fourth Hospital of People
Shenyang, , China
Xinmin People's Hospital
Shenyang, , China
Jingxing County Hospital
Shijiazhuang, , China
Laoting Hospital
Tangshan, , China
Wuchuan People's Hospital
Wuchuan, , China
Wuhai People's Hospital
Wuhai, , China
Affiliated PuAi Hospital of Tongji Medical College
Wuhan, , China
Wuyishan Municipal Hospital
Wuyishan, , China
Qinghai Cardiovascular Hospital
Xining, , China
Feng County People's Hospita
Xuzhou, , China
Yongcheng People's Hospital
Yongcheng, , China
Jiang Hua Yao Autonomous County People's Hospital
Yongzhou, , China
The First People's Hospital of YueYang
Yueyang, , China
Zhangye People's Hospital
Zhangye, , China
Dancheng County People's Hospital
Zhoukou, , China
Huaiyang County People's Hospital
Zhoukou, , China
Foundation Cardiomet Cequin
Armenia, , Colombia
Centro de Diagnostico Cardiologico Ltda
Cartagena, , Colombia
Hawkes Bay Hospital
Hastings, , New Zealand
Nelson Hospital
Nelson, , New Zealand
Taranaki Hospital
New Plymouth, , New Zealand
Rotorua Hospital
Rotorua, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Thames Hospital
Thames, , New Zealand
Whangarei Base Hopsital
Whangarei, , New Zealand
Hospital Regional Lamabayeque
Chiclayo, , Peru
Clínica Internacional
Lima, , Peru
Clínica San Pablo
Lima, , Peru
Hospital Cayetano Heredia
Lima, , Peru
Hospital Hipólito Unanue
Lima, , Peru
Regional State Budget Healthcare Institution Altai Regional Cardiology Dispensary
Barnaul, , Russia
State Healthcare Institution "Belgorod regional clinical hospital named after Prelate Ioasaf
Belgorod, , Russia
State Budget Healthcare Institution "Chelyabinsk regional clinical hospital #3"
Chelyabinsk, , Russia
State Budget Healthcare Institution Leningrad region Gatchina Clinical Inter-district Hospital
Gatchina, , Russia
State Healthcare Institution Irkutsk regional clinical hospital
Irkutsk, , Russia
Kirov Regional State Budget Healthcare Institution Kirov City clinical hospital #1
Kirov, , Russia
Regional State Budget Healthcare Institution Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk, , Russia
Municipal Healthcare Institution Lyubertsy regional Hospital #2
Lyubertsy, , Russia
State Regional Budget Healthcare Institution Murmansk region Clinical Hospital named after P.A. Bayandin
Murmansk, , Russia
State Budget Healthcare Institution Novosibirsk region City Clinical Hospital #34
Novosibirsk, , Russia
Institution of the Russian academy of sciences Hospital of Pushchino Research Center of RAS
Pushchino, , Russia
Municipal Budget Healthcare Institution Rostov-on-Don City Emergency Care Hospital
Rostov-on-Don, , Russia
State Budget Healthcare Institution Ryazan region Regional Clinical Hospital
Ryazan, , Russia
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, , Russia
Federal State Budget Science Institution "Science and Research Institute of Cardiology"
Tomsk, , Russia
State Healthcare Institution of Tula Region "Tula regional clinical hospital
Tula, , Russia
Tver Regional Clinical Hospital
Tver', , Russia
State Budget Healthcare Institution Vladimir region City Hospital #4
Vladimir, , Russia
Budget Healthcare Institution Voronezh region City Clinical Emergency Care Hospital #1
Voronezh, , Russia
State Budget Healthcare Institution of Yaroslavl region "Regional clinical hospital"
Yaroslavl, , Russia
Cherkasy Regional Cardiology Center, Department of Acute Heart Failure and Arrythmia
Cherkasy, , 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
Ivano-Frankivsk, , 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
Kharkiv, , 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
Kyiv, , Ukraine
City Clinical Hospital # 1
Mykolaiv, , Ukraine
MI "City Clinical Hospital N3 named after prof. K.J. Alejnikovoi", department of intensice cardiology care unit
Odesa, , Ukraine
MI "Rivne Regional Clinical Hospital"
Rivne, , Ukraine
Sumy regional Cardiology Dispensary
Sumy, , Ukraine
MI "Regional Medical Center of Cardiovascular Diseases" of Zaporizhzhia Regional Council, Intensive Care Unit
Zaporizhzhya, , Ukraine
Municipal Institution " Central city clinical hospital N1", cardiology department for MI patients
Zhytomyr, , Ukraine
Countries
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References
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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.
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.
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.
Other Identifiers
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TREAT01
Identifier Type: -
Identifier Source: org_study_id
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