A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI
NCT ID: NCT01149044
Last Updated: 2015-10-20
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
NA
10732 participants
INTERVENTIONAL
2010-08-31
2015-10-31
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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Upfront Thrombectomy followed by PCI
Upfront manual aspiration thrombectomy followed by PCI
Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
PCI Alone
PCI without upfront manual aspiration thrombectomy
Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
Interventions
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Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
Eligibility Criteria
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Inclusion Criteria
* Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
* Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
2. Referred for primary PCI
3. Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
4. Informed consent
Exclusion Criteria
2. Prior coronary artery bypass surgery (CABG)
3. Life expectancy less than six months due to non-cardiac condition
4. Treatment with fibrinolytic therapy for qualifying index STEMI event
19 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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Dr. Sanjit S. Jolly
MD MSc, FRCP(C), Interventional Cardiologist, Assistant Professor
Principal Investigators
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Sanjit S. Jolly, MD, MSc, FRCP
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Vladimir Džavík, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Peter Munk Cardiac Centre, University Health Network
Locations
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Central Cardiology medical Clinic
Bakersfield, California, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Lindner Research Center at Christ Hospital
Cincinnati, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Geisinger Clinic
Danville, Pennsylvania, United States
WPAHS - Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Northeast Clinical Trials Group
Scranton, Pennsylvania, United States
Royal North Shore Hospital
Sydney, New South Wales, Australia
St. George Public Hospital
Sydney, New South Wales, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Medical University of Vienna
Vienna, , Austria
CHR de la Citadelle
Liège, , Belgium
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Santa Isabel
Blumenau, Santa Catarina, Brazil
Santa Casa de Marilia
Marília, São Paulo, Brazil
Fundação Faculdade de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Mae de Deus
Porto Elegre, , Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, , Brazil
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute
Victoria, British Columbia, Canada
Royal Columbian Hospital
Westminster, British Columbia, Canada
Queen Elizabeth II Health Sciences
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
York PCI Group - Southlake Regional
Newmarket, Ontario, Canada
Scarborough Cardiology Research
Scarborough Village, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
CSSS de Chicoutimi
Chicoutimi, Quebec, Canada
MUHC Royal Victoria Hospital
Montreal, Quebec, Canada
Quebec Heart Lung Insitute
Québec, Quebec, Canada
Shanghai Gongli Hospital
Shanghai, , China
The First People's Hospital, Jiatong University
Shanghai, , China
The Tenth People's Hospital Tongji University
Shanghai, , China
Yueyang Hospital Shanghai University of TCM
Shanghai, , China
Krasjska Nemocnice Liberec
Liberec, , Czechia
University Hospital Pilsen
Pilsen, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
Masaryk Hospital
Ústí nad Labem, , Czechia
Kuopio University Hospital
Kuopio, , Finland
Heart Center, Tampere University Hospital
Tampere, , Finland
Chu Jean Minjoz
Besançon, , France
CHU Albert Michallon
Grenoble, , France
Hopital Bichat
Paris, , France
Hopital Lariboisiere Ap-HP
Paris, , France
Centre Hospitalier de Pau
Pau, , France
Universitatsklinikum Bonn
Bonn, , Germany
Elisabeth-Krankenhaus Essen
Essen, , Germany
Clinical Association Oberallgaeu-Kempten
Immenstadt im Allgäu, , Germany
Klinikum der Universitat Munchen
München, , Germany
Patras University Hospital
Pátrai, , Greece
Ahepa University Hospital
Thessaloniki, , Greece
Semmelweis University Heart and Vascular Center
Budapest, , Hungary
University of Szeged
Szeged, , Hungary
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Waikato Hospital
Hamilton, , New Zealand
Medical University Skopje
Skopje, , North Macedonia
Clinical Center of Serbia
Belgrade, , Serbia
Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Kyung-Hee University Hospital
Seoul, , South Korea
Seoul Boramae Medical Center
Seoul, , South Korea
Hospital Universitari Germans Trias I Pujol
Baldona, , Spain
Complexo Hospitalario A Coruna
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
University Hospital La Paz
Madrid, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Hospital Clinico Universitario de Vigo
Vigo, , Spain
Hampshire Hospitals NHS Fuondation Trust
Basingstoke, , United Kingdom
Barts and The London Heart and Chest Centre
Bethnal Green, , United Kingdom
Frimley Park Hospital, NHS Foundation Trust
Camberley, , United Kingdom
Hull and East Yorkshire Hospitals
Hull, , United Kingdom
Kettering General Hospital
Kettering, , United Kingdom
Glenfield General Hospital
Leicester, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
University Hospital South Manchester
Manchester, , United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, , United Kingdom
Sheffield Teaching Hospitals
Sheffield, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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References
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Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemela K, Steg PG, Bertrand OF, Rao SV, Avezum A, Cantor WJ, Pancholy SB, Moreno R, Gershlick A, Bhindi R, Welsh RC, Cheema AN, Lavi S, Rokoss M, Dzavik V. Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI. Am Heart J. 2014 Mar;167(3):315-321.e1. doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.
Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.
Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, Cantor WJ, Overgaard CB, Lavi S, Sharma V, Chowdhary S, Stankovic G, Kedev S, Bernat I, Bhindi R, Sheth T, Niemela K, Jolly SS, Dzavik V. Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011336. doi: 10.1161/CIRCINTERVENTIONS.121.011336. Epub 2022 May 17.
Moxham R, Dzavik V, Cairns J, Natarajan MK, Bainey KR, Akl E, Tsang MB, Lavi S, Cantor WJ, Madan M, Liu YY, Jolly SS. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial. JAMA Netw Open. 2021 Mar 1;4(3):e213505. doi: 10.1001/jamanetworkopen.2021.3505.
Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Dzavik V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.
Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemela K, Natarajan MK, Shestakovska O, Tittarelli R, Meeks B, Jolly SS. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial. Circ Cardiovasc Interv. 2016 Apr;9(4):e003414. doi: 10.1161/CIRCINTERVENTIONS.115.003414.
Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Dzavik V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22.
Jolly SS, Cairns JA, Yusuf S, Meeks B, Gao P, Hart RG, Kedev S, Stankovic G, Moreno R, Horak D, Kassam S, Rokoss MJ, Leung RC, El-Omar M, Romppanen HO, Alazzoni A, Alak A, Fung A, Alexopoulos D, Schwalm JD, Valettas N, Dzavik V; TOTAL Investigators. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. Eur Heart J. 2015 Sep 14;36(35):2364-72. doi: 10.1093/eurheartj/ehv296. Epub 2015 Jun 29.
Williams PD, Mamas MA, Fraser DG. A coronary artery cast. Can J Cardiol. 2011 Nov-Dec;27(6):871.e5-6. doi: 10.1016/j.cjca.2011.08.108. Epub 2011 Oct 14. No abstract available.
Related Links
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TOTAL - A Randomized Trial of Routine Aspiration Thrombectomy with Percutaneous Coronary Intervention (PCI) vs. PCI Alone in Patients with STEMI Undergoing Primary PCI (Population Health Research Institute)
Other Identifiers
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TOTAL Trial
Identifier Type: -
Identifier Source: org_study_id
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