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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:
ClinicalTrials.gov Identifier:
NCT01149044
First Posted: June 23, 2010
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Sanjit S. Jolly, Population Health Research Institute
June 22, 2010
June 23, 2010
October 20, 2015
August 2010
March 2015   (Final data collection date for primary outcome measure)
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 ]
The composite of cardiovascular death, recurrent MI, cardiogenic shock, or new or worsening NYHA Class IV heart failure is the primary outcome at 180 days [ Time Frame: 180 days ]
Complete list of historical versions of study NCT01149044 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Stroke
  • Device related complications
  • Major bleeding
  • Components of primary outcome at 30 days, 180 days and one year
  • 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 ]
Not Provided
 
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 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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • ST Elevation Myocardial Infarction
  • Percutaneous Coronary Intervention
Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
  • Active Comparator: Upfront Thrombectomy followed by PCI
    Upfront manual aspiration thrombectomy followed by PCI
    Intervention: Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
  • Active Comparator: PCI Alone
    PCI without upfront manual aspiration thrombectomy
    Intervention: Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10732
October 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hungary,   Korea, Republic of,   Macedonia, The Former Yugoslav Republic of,   Netherlands,   New Zealand,   Serbia,   Spain,   United Kingdom,   United States
 
 
NCT01149044
TOTAL Trial
Yes
Not Provided
Not Provided
Dr. Sanjit S. Jolly, Population Health Research Institute
Population Health Research Institute
Not Provided
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
Population Health Research Institute
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP