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Acute Coronary SyndromeTOTALNCT01149044

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

A study testing Percutaneous Coronary Intervention with or without manual aspiration thrombectomy in people with Acute Coronary Syndrome and ST Elevation Myocardial Infarction, run by Population Health Research Institute at 87 sites in 20 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

This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,732 participants
Where
87 sitesin 20 countries
Study dates
Aug 2010to Oct 2015
Phase
Interventional
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients presenting with:
  • 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
  • Referred for primary PCI
  • Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
  • Informed consent

Who cannot join

  • Age ≤ 18 years
  • Prior coronary artery bypass surgery (CABG)
  • Life expectancy less than six months due to non-cardiac condition
  • Treatment with fibrinolytic therapy for qualifying index STEMI event

Trial locations and contacts

87 sites in 20 countries.

87 sites in 20 countries

Canada15 sites

  • CSSS de Chicoutimi

    Chicoutimi, Quebec

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • University of Alberta

    Edmonton, Alberta

  • Queen Elizabeth II Health Sciences

    Halifax, Nova Scotia

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • London Health Sciences Centre

    London, Ontario

  • MUHC Royal Victoria Hospital

    Montreal, Quebec

  • York PCI Group - Southlake Regional

    Newmarket, Ontario

  • Quebec Heart Lung Insitute

    Québec, Quebec

  • Scarborough Cardiology Research

    Scarborough Village, Ontario

  • St. Michael's Hospital

    Toronto, Ontario

  • Toronto General Hospital

    Toronto, Ontario

  • Vancouver General Hospital

    Vancouver, British Columbia

  • Victoria Heart Institute

    Victoria, British Columbia

  • Royal Columbian Hospital

    Westminster, British Columbia

Other trials in Canada

United Kingdom12 sites

  • Hampshire Hospitals NHS Fuondation Trust

    Basingstoke

  • Barts and The London Heart and Chest Centre

    Bethnal Green

  • Frimley Park Hospital, NHS Foundation Trust

    Camberley

  • Hull and East Yorkshire Hospitals

    Hull

  • Kettering General Hospital

    Kettering

  • Glenfield General Hospital

    Leicester

  • Manchester Royal Infirmary

    Manchester

  • University Hospital South Manchester

    Manchester

  • Queen Elizabeth the Queen Mother Hospital

    Margate

  • Sheffield Teaching Hospitals

    Sheffield

  • University Hospital Southampton

    Southampton

  • Musgrove Park Hospital

    Taunton

Other trials in United Kingdom

United States8 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Central Cardiology medical Clinic

    Bakersfield, California, 93308

  • Lindner Research Center at Christ Hospital

    Cincinnati, Ohio, 45219

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • WPAHS - Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Northeast Clinical Trials Group

    Scranton, Pennsylvania, 18510

Other trials in United States

Spain8 sites

  • Hospital Universitari Germans Trias I Pujol

    Baldona

  • Complexo Hospitalario A Coruna

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital Clinico San Carlos

    Madrid

  • University Hospital La Paz

    Madrid

  • Hospital Son Espases

    Palma de Mallorca

  • Hospital Clinico Universitario de Vigo

    Vigo

Other trials in Spain

Brazil7 sites

  • Hospital Santa Isabel

    Blumenau, Santa Catarina

  • Santa Casa de Marilia

    Marília, São Paulo

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital Mae de Deus

    Porto Elegre

  • Fundação Faculdade de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo

Other trials in Brazil

Czechia5 sites

  • Krasjska Nemocnice Liberec

    Liberec

  • University Hospital Pilsen

    Pilsen

  • University Hospital Kralovske Vinohrady

    Prague

  • University Hospital Motol

    Prague

  • Masaryk Hospital

    Ústí nad Labem

Other trials in Czechia

France5 sites

  • Chu Jean Minjoz

    Besançon

  • CHU Albert Michallon

    Grenoble

  • Hopital Bichat

    Paris

  • Hopital Lariboisiere Ap-HP

    Paris

  • Centre Hospitalier de Pau

    Pau

Other trials in France

China4 sites

  • Shanghai Gongli Hospital

    Shanghai

  • The First People's Hospital, Jiatong University

    Shanghai

  • The Tenth People's Hospital Tongji University

    Shanghai

  • Yueyang Hospital Shanghai University of TCM

    Shanghai

Other trials in China

Germany4 sites

  • Universitatsklinikum Bonn

    Bonn

  • Elisabeth-Krankenhaus Essen

    Essen

  • Clinical Association Oberallgaeu-Kempten

    Immenstadt im Allgäu

  • Klinikum der Universitat Munchen

    München

Other trials in Germany

South Korea4 sites

  • Soonchunhyang University Cheonan Hospital

    Cheonan

  • Chonnam National University Hospital

    Gwangju

  • Kyung-Hee University Hospital

    Seoul

  • Seoul Boramae Medical Center

    Seoul

Other trials in South Korea

Australia3 sites

  • Gold Coast Hospital

    Southport, Queensland

  • Royal North Shore Hospital

    Sydney, New South Wales

  • St. George Public Hospital

    Sydney, New South Wales

Other trials in Australia

Finland2 sites

  • Kuopio University Hospital

    Kuopio

  • Heart Center, Tampere University Hospital

    Tampere

Other trials in Finland

Greece2 sites

  • Patras University Hospital

    Pátrai

  • Ahepa University Hospital

    Thessaloniki

Other trials in Greece

Hungary2 sites

  • Semmelweis University Heart and Vascular Center

    Budapest

  • University of Szeged

    Szeged

Other trials in Hungary

Austria1 site

  • Medical University of Vienna

    Vienna

Other trials in Austria

Belgium1 site

  • CHR de la Citadelle

    Liège

Other trials in Belgium

Netherlands1 site

  • St. Antonius Ziekenhuis

    Nieuwegein

Other trials in Netherlands

New Zealand1 site

  • Waikato Hospital

    Hamilton

Other trials in New Zealand

North Macedonia1 site

  • Medical University Skopje

    Skopje

Other trials in North Macedonia

Serbia1 site

  • Clinical Center of Serbia

    Belgrade

Other trials in Serbia

About this study

Official title: TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

Read the detailed description

The hypothesis for TOTAL is that the routine use of manual aspiration thrombectomy with an aspiration catheter (Export®) with PCI compared to PCI alone will reduce the incidence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure (HF) at 180 days in patients with STEMI undergoing primary PCI.

Being tested
Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
Keywords
Acute Coronary Syndrome, PCI, Percutaneous Coronary Intervention, STEMI, Thrombectomy
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction

What participants receive

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

  • Percutaneous Coronary Intervention with or without manual aspiration thrombectomyProcedure or surgery

Study groups in NCT01149044
Study groupRoleWhat they receive
Upfront Thrombectomy followed by PCIActive comparatorUpfront manual aspiration thrombectomy followed by PCI
Receives: Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
PCI AloneActive comparatorPCI without upfront manual aspiration thrombectomy
Receives: Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

What is being measured

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

  1. The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure

    Measured: up to 180 days

Secondary outcomes (4)

  1. Stroke

    Measured: up to 30 days

  2. Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure

    Measured: up to 1 year

  3. Cardiovascular Mortality

    Measured: up to 180 days

  4. Key Secondary Efficacy Outcome: The first occurence of cardiovascular death, myocardial infarction, cardiogenic shock, new or worsening NYHA class IV heart failure, stent thrombosis and target vessel revascularization

    Measured: up to 180 days

Timeline

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

  1. First posted23 Jun 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2015
  4. Study completionOct 2015

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10,732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01149044
Sponsor's protocol ID
TOTAL Trial
Acronym
TOTAL
Status last verified
Oct 2015
First submitted
22 Jun 2010
Last updated
20 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24576514

  • 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.

    PubMed 25853743

  • 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.

    PubMed 35580203

  • 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.

    PubMed 33769510

  • 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.

    PubMed 30261959

  • 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.

    PubMed 27056766

  • 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.

    PubMed 26474811

  • 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.

    PubMed 26129947

  • 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.

    PubMed 22000582

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention with or without manual aspiration thrombectomy in people with Acute Coronary Syndrome and ST Elevation Myocardial Infarction, run by Population Health Research Institute at 87 sites in 20 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 4 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 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Canada, United Kingdom, United States, Spain, Brazil and 15 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.

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?

The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure (time frame: up to 180 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 NCT01149044, which also lists 9 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 20 Oct 2015.

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