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 ongoing, but not recruiting participants.
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: December 11, 2014
Last verified: December 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 ]

Enrollment: 10732
Study Start Date: August 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 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

  Hide Study Locations
Locations
United States, California
Central Cardiology medical Clinic
Bakersfield, California, United States, 93308
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Lindner Research Center at Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Geisinger Clinic
Danville, Pennsylvania, United States, 17822
WPAHS - Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Northeast Clinical Trials Group
Scranton, Pennsylvania, United States, 18510
Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia
St. George Public Hospital
Sydney, New South Wales, Australia
Australia, Queensland
Gold Coast Hospital
Southport, Queensland, Australia
Austria
Medical University of Vienna
Vienna, Austria
Belgium
CHR de la Citadelle
Lige, Belgium
Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil
Hospital Santa Isabel
Blumenau, Santa Catarina, Brazil
Santa Casa de Marilia
Marilia, Sao Paulo, Brazil
Fundação Faculdade de Medicina de São José do Rio Preto
Sao Jose do Rio Preto, Sao Paulo, Brazil
Hospital Mae de Deus
Porto Elegre, Brazil
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute
Victoria, British Columbia, Canada
Royal Columbian Hospital
Westminster, British Columbia, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre
London, Ontario, Canada
York PCI Group - Southlake Regional
Newmarket, Ontario, Canada
Scarborough Cardiology Research
Scarborough, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Canada, Quebec
CSSS de Chicoutimi
Chicoutimi, Quebec, Canada
MUHC Royal Victoria Hospital
Montreal, Quebec, Canada
Quebec Heart Lung Insitute
Quebec City, Quebec, Canada
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
Shanghai, China
Czech Republic
Krasjska Nemocnice Liberec
Liberec, Czech Republic
University Hospital Pilsen
Pilsen, Czech Republic
University Hospital Motol
Prague, Czech Republic
University Hospital Kralovske Vinohrady
Praha, Czech Republic
Masaryk Hospital
Usti nad Labem, Czech Republic
Finland
Kuopio University Hospital
Kuopio, Finland
Heart Center, Tampere University Hospital
Tampere, Finland
France
Chu Jean Minjoz
Besancon, France
CHU Albert Michallon
Grenoble, France
Hopital Bichat
Paris, France
Hopital Lariboisiere Ap-HP
Paris, France
Centre Hospitalier de Pau
Pau, France
Germany
Universitatsklinikum Bonn
Bonn, Germany
Elisabeth-Krankenhaus Essen
Essen, Germany
Clinical Association Oberallgaeu-Kempten
Immenstadt, Germany
Klinikum der Universitat Munchen
Munchen, Germany
Greece
Patras University Hospital
Patras, Greece
Ahepa University Hospital
Thessaloniki, Greece
Hungary
Semmelweis University Heart and Vascular Center
Budapest, Hungary
University of Szeged
Szeged, Hungary
Korea, Republic of
Soonchunhyang University Cheonan Hospital
Cheonan, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Seoul Boramae Medical Center
Seoul, Korea, Republic of
Kyung-Hee University Hospital
Seoul, Korea, Republic of
Macedonia, The Former Yugoslav Republic of
Medical University Skopje
Skopje, Macedonia, The Former Yugoslav Republic of
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
New Zealand
Waikato Hospital
Hamilton, New Zealand
Serbia
Clinical Center of Serbia
Belgrade, Serbia
Spain
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
United Kingdom
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
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: December 11, 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:
Acute Coronary Syndrome
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on March 26, 2015