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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)

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ClinicalTrials.gov Identifier: NCT01149044
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome ST Elevation Myocardial Infarction Percutaneous Coronary Intervention 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2010
Primary Completion Date : March 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Stroke [ Time Frame: 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 [ Time Frame: up to 1 year ]
  3. Cardiovascular Mortality [ Time Frame: 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 [ Time Frame: up to 180 days ]

Other Outcome Measures:
  1. Primary outcome at 30 days and 1 year [ Time Frame: up to 1 year ]
  2. 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

  3. All-cause mortality [ Time Frame: up to 1 year ]
    All-cause mortality at 30 days, 180 days and 1 year

  4. 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

  5. TIMI flow rates, no reflow [ Time Frame: up to 1 year ]
  6. Stent thrombosis [ Time Frame: up to 1 year ]
  7. Distal embolization [ Time Frame: up to 1 year ]
  8. Left main thrombus as a complication of the PCI procedure [ Time Frame: up to 1 year ]
  9. Target Vessel dissection [ Time Frame: up to 1 year ]
  10. Left main dissection [ Time Frame: up to 1 year ]
  11. Major Bleeding [ Time Frame: up to 1 year ]

Eligibility Criteria

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Dr. Sanjit S. Jolly, Population Health Research Institute:
Acute Coronary Syndrome
PCI
Percutaneous Coronary Intervention
STEMI
Thrombectomy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases