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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Population Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Dr. Sanjit S. Jolly, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01149044
First received: June 22, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Percutaneous Coronary Intervention
Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stroke [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Cardiovascular Mortality [ Time Frame: up to 180 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Primary outcome at 30 days and 1 year [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Components of primary outcome and secondary outcomes [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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

  • All-cause mortality [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    All-cause mortality at 30 days, 180 days and 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 ] [ Designated as safety issue: No ]
    Composite of cardiovascular death, myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days

  • TIMI flow rates, no reflow [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Distal embolization [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Left main thrombus as a complication of the PCI procedure [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Target Vessel dissection [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Left main dissection [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Major Bleeding [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10700
Study Start Date: August 2010
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149044

Contacts
Contact: Brandi L Meeks, M.Eng. 905 527 4322 ext 40442 total@phri.ca

  Hide Study Locations
Locations
United States, California
Central Cardiology medical Clinic Recruiting
Bakersfield, California, United States, 93308
Contact: Dr. S. Singh       total@phri.ca   
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Dr. C. Devireddy       total@phri.ca   
United States, New Mexico
University of New Mexico Health Sciences Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Dr. M. Sheldon       total@phri.ca   
United States, Ohio
Lindner Research Center at Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dr. I. Sarembock       total@phri.ca   
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Dr. N. Patel       total@phri.ca   
Geisinger Clinic Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Dr. J. Blankenship       total@phri.ca   
WPAHS - Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Dr. D. Lasorda       total@phri.ca   
Northeast Clinical Trials Group Recruiting
Scranton, Pennsylvania, United States, 18510
Contact: Dr. S. Pancholy       total@phri.ca   
Australia, New South Wales
Royal North Shore Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Dr. R. Bhindi       total@phri.ca   
St. George Public Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Dr. J. Weaver       total@phri.ca   
Australia, Queensland
Gold Coast Hospital Recruiting
Southport, Queensland, Australia
Contact: Dr. A. Rahman       total@phri.ca   
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Prof. I. Lang       total@phri.ca   
Belgium
CHR de la Citadelle Recruiting
Lige, Belgium
Contact: Dr. S. Pourbaix       total@phri.ca   
Brazil
Hospital Sao Lucas - PUCRS Recruiting
Porto Alegre, RS, Brazil
Contact: Dr. P. Caramori       total@phri.ca   
Irmandade da Santa Casa de Misericórdia de Porto Alegre Recruiting
Porto Alegre, RS, Brazil
Contact: Dr. V. Lima       total@phri.ca   
Hospital Santa Isabel Recruiting
Blumenau, Santa Catarina, Brazil
Contact: Dr. A. Kormann       total@phri.ca   
Santa Casa de Marilia Recruiting
Marilia, Sao Paulo, Brazil
Contact: Dr. M.A. Tebet       total@phri.ca   
Fundação Faculdade de Medicina de São José do Rio Preto Recruiting
Sao Jose do Rio Preto, Sao Paulo, Brazil
Contact: Dr. M.A. dos Santos       total@phri.ca   
Hospital Mae de Deus Recruiting
Porto Elegre, Brazil
Contact: Dr. A. Zago       total@phri.ca   
Instituto Dante Pazzanese de Cardiologia Recruiting
Sao Paulo, Brazil
Contact: Dr. A. Abizaid       total@phri.ca   
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Dr. R. Welsh       total@phri.ca   
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Dr. R. Leung       total@phri.ca   
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Dr. A. Fung       total@phri.ca   
Victoria Heart Institute Recruiting
Victoria, British Columbia, Canada
Contact: Dr. A. Della Siega       total@phri.ca   
Royal Columbian Hospital Recruiting
Westminster, British Columbia, Canada
Contact: Dr. J. Charania       total@phri.ca   
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Active, not recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Dr. S. Jolly       total@phri.ca   
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Dr. S. Lavi       total@phri.ca   
York PCI Group - Southlake Regional Recruiting
Newmarket, Ontario, Canada
Contact: Dr. W. Cantor       total@phri.ca   
Scarborough Cardiology Research Recruiting
Scarborough, Ontario, Canada
Contact: Dr. S. Kassam       total@phri.ca   
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Dr. A. Cheema       total@phri.ca   
Toronto General Hospital Recruiting
Toronto, Ontario, Canada
Contact: Dr. V. Dzavik       total@phri.ca   
Canada, Quebec
CSSS de Chicoutimi Recruiting
Chicoutimi, Quebec, Canada
Contact: Dr. T. Cieza       total@phri.ca   
MUHC Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada
Contact: Dr. L. Bilodeau       total@phri.ca   
Quebec Heart Lung Insitute Recruiting
Quebec City, Quebec, Canada
Contact: Dr. O. Bertrand       total@phri.ca   
China
The First People's Hospital, Jiatong University Recruiting
Shanghai, China
Contact: Dr. S. Liu       total@phri.ca   
The Tenth People's Hospital Tongji University Recruiting
Shanghai, China
Contact: Prof. Y. Xu       total@phri.ca   
Shanghai Gongli Hospital Recruiting
Shanghai, China
Contact: Dr. J. Qiu       total@phri.ca   
Yueyang Hospital Shanghai University of TCM Recruiting
Shanghai, China
Contact: Dr. H. Luo       total@phri.ca   
Czech Republic
Krasjska Nemocnice Liberec Recruiting
Liberec, Czech Republic
Contact: Dr. D. Horak       total@phri.ca   
University Hospital Pilsen Recruiting
Pilsen, Czech Republic
Contact: Dr. I. Bernat       total@phri.ca   
University Hospital Motol Recruiting
Prague, Czech Republic
Contact: Dr. P. Hajek       total@phri.ca   
University Hospital Kralovske Vinohrady Active, not recruiting
Praha, Czech Republic
Masaryk Hospital Active, not recruiting
Usti nad Labem, Czech Republic
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Dr. H. Romppanen       total@phri.ca   
Heart Center, Tampere University Hospital Recruiting
Tampere, Finland
Contact: Prof. K. Niemela       total@phri.ca   
France
Chu Jean Minjoz Recruiting
Besancon, France
Contact: Prof. F. Schiele       total@phri.ca   
CHU Albert Michallon Recruiting
Grenoble, France
Contact: Dr. S. Marliere       total@phri.ca   
Hopital Bichat Active, not recruiting
Paris, France
Hopital Lariboisiere Ap-HP Recruiting
Paris, France
Contact: Dr. G. Sideris       total@phri.ca   
Centre Hospitalier de Pau Recruiting
Pau, France
Contact: Dr. N. Delarche       total@phri.ca   
Germany
Universitatsklinikum Bonn Recruiting
Bonn, Germany
Contact: Prof. N. Werner       total@phri.ca   
Elisabeth-Krankenhaus Essen Recruiting
Essen, Germany
Contact: Dr. C. Naber       total@phri.ca   
Clinical Association Oberallgaeu-Kempten Recruiting
Immenstadt, Germany
Contact: Prof. J. Torzewski       total@phri.ca   
Klinikum der Universitat Munchen Recruiting
Munchen, Germany
Contact: Dr. M. Greif       total@phri.ca   
Greece
Patras University Hospital Recruiting
Patras, Greece
Contact: Prof. D. Alexopoulos       total@phri.ca   
Ahepa University Hospital Recruiting
Thessaloniki, Greece
Contact: Dr. A. Ziakas       total@phri.ca   
Hungary
Semmelweis University Heart and Vascular Center Recruiting
Budapest, Hungary
Contact: Prof. B. Merkely       total@phri.ca   
University of Szeged Recruiting
Szeged, Hungary
Contact: Prof. I. Ungi       total@phri.ca   
Korea, Republic of
Soonchunhyang University Cheonan Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Dr. Seung Jin Lee       total@phri.ca   
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Dr. Myung-Ho Jeong       total@phri.ca   
Seoul Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Dr. S-H. Kim       total@phri.ca   
Kyung-Hee University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Prof. Weon Kim       total@phri.ca   
Macedonia, The Former Yugoslav Republic of
Medical University Skopje Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Contact: Prof. S. Kedev       total@phri.ca   
Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: Prof. J.M. ten Berg       total@phri.ca   
New Zealand
Waikato Hospital Recruiting
Hamilton, New Zealand
Contact: Dr. G. Devlin       total@phri.ca   
Serbia
Clinical Center of Serbia Recruiting
Belgrade, Serbia
Contact: Prof. G. Stankovic       total@phri.ca   
Spain
Hospital Universitari Germans Trias I Pujol Recruiting
Baldona, Spain
Contact: Dr. J. Mauri       total@phri.ca   
Complexo Hospitalario A Coruna Recruiting
Barcelona, Spain
Contact: Dr. N. Vazquez       total@phri.ca   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Dr. B. Garcia del Blanco       total@phri.ca   
University Hospital La Paz Recruiting
Madrid, Spain
Contact: Dr. R. Moreno Gomez       total@phri.ca   
Hospital Clinico San Carlos Active, not recruiting
Madrid, Spain
Hospital Son Espases Recruiting
Palma de Mallorca, Spain
Contact: Dr. A. Bethencourt       total@phri.ca   
Hospital Clinico Universitario de Vigo Recruiting
Vigo, Spain
Contact: Dr. A. Iniguez Romo       total@phri.ca   
United Kingdom
Hampshire Hospitals NHS Fuondation Trust Recruiting
Basingstoke, United Kingdom
Contact: Dr. J. Glover       total@phri.ca   
Barts and The London Heart and Chest Centre Recruiting
Bethnal Green, United Kingdom
Contact: Dr. A. Jain       total@phri.ca   
Frimley Park Hospital, NHS Foundation Trust Recruiting
Camberley, United Kingdom
Contact: Dr. J. Shannon       total@phri.ca   
Hull and East Yorkshire Hospitals Recruiting
Hull, United Kingdom
Contact: Dr. S. Thackray       total@phri.ca   
Kettering General Hospital Recruiting
Kettering, United Kingdom
Contact: Dr. S. Hetherington       total@phri.ca   
Glenfield General Hospital Recruiting
Leicester, United Kingdom
Contact: Prof. A. Gershlick       total@phri.ca   
University Hospital South Manchester Recruiting
Manchester, United Kingdom
Contact: Dr. S. Chowdary       total@phri.ca   
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Contact: Dr. M. El-Omar       total@phri.ca   
Queen Elizabeth the Queen Mother Hospital Recruiting
Margate, United Kingdom
Contact: Dr. K. Grosser       total@phri.ca   
Sheffield Teaching Hospitals Recruiting
Sheffield, United Kingdom
Contact: Dr. J. Gunn       total@phri.ca   
University Hospital Southampton Recruiting
Southampton, United Kingdom
Contact: Dr. N. Curzen       total@phri.ca   
Musgrove Park Hospital Recruiting
Taunton, United Kingdom
Contact: Dr. M. Seddon       total@phri.ca   
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided by Population Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Sanjit S. Jolly, MD MSc, FRCP(C), Interventional Cardiologist, Assistant Professor, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01149044     History of Changes
Other Study ID Numbers: TOTAL Trial
Study First Received: June 22, 2010
Last Updated: May 27, 2014
Health Authority: Canada: Research Ethics Board
United States: U.S. Food and Drug Administration, Institutional Review Board
Australia: Ethics Committee
Austria: Ethics Committee
Brazil: Ethics Committee
Belgium: Ethics Committee
China: Ethics Committee
Czech Republic: Ethics Committee
Finland: Ethics Committee
France: Ethics Committee
Germany: Ethics Committee
Greece: Ethics Committee
Hungary: Ethics Committee
Macedonia: Ethics Committee
Netherlands: Ethics Committee
New Zealand: Ethics Committee
Serbia: Ethics Committee
South Korea: Ethics Committee
Spain: Ethics Committee
United Kingdom: Ethics Committee

Keywords provided by Population Health Research Institute:
Acute Coronary Syndrome
PCI
Percutaneous Coronary Intervention
STEMI
Thrombectomy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014