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 (TOTAL)

October 19, 2015 updated by: Dr. Sanjit S. Jolly, Population Health Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10732

Phase

  • Not Applicable

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australia
        • St. George Public Hospital
    • Queensland
      • Southport, Queensland, Australia
        • Gold Coast Hospital
  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • Belgium
      • Lige, Belgium
        • CHR de la Citadelle
  • Brazil
      • Porto Elegre, Brazil
        • Hospital Mae de Deus
      • Sao Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
    • RS
      • Porto Alegre, RS, Brazil
        • Hospital São Lucas - PUCRS
      • Porto Alegre, RS, Brazil
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil
        • Hospital Santa Isabel
    • Sao Paulo
      • Marilia, Sao Paulo, Brazil
        • Santa Casa de Marília
      • Sao Jose do Rio Preto, Sao Paulo, Brazil
        • Fundação Faculdade de Medicina de São José do Rio Preto
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
      • Victoria, British Columbia, Canada
        • Victoria Heart Institute
      • Westminster, British Columbia, Canada
        • Royal Columbian Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth II Health Sciences
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Newmarket, Ontario, Canada
        • York PCI Group - Southlake Regional
      • Scarborough, Ontario, Canada
        • Scarborough Cardiology Research
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Toronto General Hospital
    • Quebec
      • Chicoutimi, Quebec, Canada
        • CSSS de Chicoutimi
      • Montreal, Quebec, Canada
        • MUHC Royal Victoria Hospital
      • Quebec City, Quebec, Canada
        • Quebec Heart Lung Insitute
  • China
      • Shanghai, China
        • 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
  • Czech Republic
      • Liberec, Czech Republic
        • Krasjska Nemocnice Liberec
      • Pilsen, Czech Republic
        • University Hospital Pilsen
      • Prague, Czech Republic
        • University Hospital Motol
      • Praha, Czech Republic
        • University Hospital Kralovske Vinohrady
      • Usti nad Labem, Czech Republic
        • Masaryk Hospital
  • Finland
      • Kuopio, Finland
        • Kuopio University Hospital
      • Tampere, Finland
        • Heart Center, Tampere University Hospital
  • France
      • Besancon, France
        • CHU Jean Minjoz
      • Grenoble, France
        • CHU Albert Michallon
      • Paris, France
        • Hopital Bichat
      • Paris, France
        • Hôpital Lariboisière AP-HP
      • Pau, France
        • Centre Hospitalier de Pau
  • Germany
      • Bonn, Germany
        • Universitätsklinikum Bonn
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen
      • Immenstadt, Germany
        • Clinical Association Oberallgaeu-Kempten
      • Munchen, Germany
        • Klinikum der Universität München
  • Greece
      • Patras, Greece
        • Patras University Hospital
      • Thessaloniki, Greece
        • Ahepa University Hospital
  • Hungary
      • Budapest, Hungary
        • Semmelweis University Heart and Vascular Center
      • Szeged, Hungary
        • University of Szeged
  • Korea, Republic of
      • Cheonan, Korea, Republic of
        • Soonchunhyang University Cheonan Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Seoul, Korea, Republic of
        • Kyung-Hee University Hospital
      • Seoul, Korea, Republic of
        • Seoul Boramae Medical Center
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • Medical University Skopje
  • Netherlands
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
  • New Zealand
      • Hamilton, New Zealand
        • Waikato Hospital
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
  • Spain
      • Baldona, Spain
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Complexo Hospitalario a Coruna
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • University Hospital La Paz
      • Palma de Mallorca, Spain
        • Hospital Son Espases
      • Vigo, Spain
        • Hospital Clinico Universitario de Vigo
  • United Kingdom
      • Basingstoke, United Kingdom
        • Hampshire Hospitals NHS Fuondation Trust
      • Bethnal Green, United Kingdom
        • Barts and The London Heart and Chest Centre
      • Camberley, United Kingdom
        • Frimley Park Hospital, NHS Foundation Trust
      • Hull, United Kingdom
        • Hull and East Yorkshire Hospitals
      • Kettering, United Kingdom
        • Kettering General Hospital
      • Leicester, United Kingdom
        • Glenfield General Hospital
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Manchester, United Kingdom
        • University Hospital South Manchester
      • Margate, United Kingdom
        • Queen Elizabeth the Queen Mother Hospital
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals
      • Southampton, United Kingdom
        • University Hospital Southampton
      • Taunton, United Kingdom
        • Musgrove Park Hospital
  • United States
    • California
      • Bakersfield, California, United States, 93308
        • Central Cardiology Medical Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Lindner Research Center at Christ Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • LeHigh Valley Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
      • Pittsburgh, Pennsylvania, United States, 15212
        • WPAHS - Allegheny General Hospital
      • Scranton, Pennsylvania, United States, 18510
        • Northeast Clinical Trials Group

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Referred for primary PCI
  3. Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
  4. Informed consent

Exclusion Criteria:

  1. Age ≤ 18 years
  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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Upfront Thrombectomy followed by PCI
Upfront manual aspiration thrombectomy followed by PCI
Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
ACTIVE_COMPARATOR: PCI Alone
PCI without upfront manual aspiration thrombectomy
Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Stroke
Time Frame: up to 30 days
up to 30 days
Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure
Time Frame: up to 1 year
up to 1 year
Cardiovascular Mortality
Time Frame: up to 180 days
up to 180 days
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
Time Frame: up to 180 days
up to 180 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome at 30 days and 1 year
Time Frame: up to 1 year
up to 1 year
Components of primary outcome and secondary outcomes
Time Frame: up to 1 year
CV death, MI, cardiogenic shock, new or worsening class IV heart failure, stroke, stent thrombosis, target vessel revascularization assessed separately at 30 days, 180 days and one year
up to 1 year
All-cause mortality
Time Frame: up to 1 year
All-cause mortality at 30 days, 180 days and 1 year
up to 1 year
Composite of CV death, MI, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days
Time Frame: up to 180 days
Composite of cardiovascular death, myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days
up to 180 days
TIMI flow rates, no reflow
Time Frame: up to 1 year
up to 1 year
Stent thrombosis
Time Frame: up to 1 year
up to 1 year
Distal embolization
Time Frame: up to 1 year
up to 1 year
Left main thrombus as a complication of the PCI procedure
Time Frame: up to 1 year
up to 1 year
Target Vessel dissection
Time Frame: up to 1 year
up to 1 year
Left main dissection
Time Frame: up to 1 year
up to 1 year
Major Bleeding
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

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

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Sanjit S. Jolly, MD, MSc, FRCP, Hamilton Health Sciences Corporation
  • Principal Investigator: Vladimir Džavík, MD, FRCPC, Peter Munk Cardiac Centre, University Health Network

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

Helpful Links

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

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (ESTIMATE)

June 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOTAL Trial

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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