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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 has been completed.
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: October 19, 2015
Last verified: October 2015
  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 ]

Secondary Outcome Measures:
  • Stroke [ Time Frame: 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 ]
  • Cardiovascular Mortality [ Time Frame: 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 ]

Other Outcome Measures:
  • Primary outcome at 30 days and 1 year [ Time Frame: 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

  • All-cause mortality [ Time Frame: up to 1 year ]
    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 ]
    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 ]
  • Stent thrombosis [ Time Frame: up to 1 year ]
  • Distal embolization [ Time Frame: up to 1 year ]
  • Left main thrombus as a complication of the PCI procedure [ Time Frame: up to 1 year ]
  • Target Vessel dissection [ Time Frame: up to 1 year ]
  • Left main dissection [ Time Frame: up to 1 year ]
  • Major Bleeding [ Time Frame: up to 1 year ]

Enrollment: 10732
Study Start Date: August 2010
Study Completion Date: October 2015
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 87 Study Locations
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:
Publications:
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: October 19, 2015

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

ClinicalTrials.gov processed this record on February 27, 2017