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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 is currently recruiting participants.
Verified May 2013 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 1, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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: 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 ]

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 [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    CV death, MI, cardiogenic shock or new or worsening class IV heart failure 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: 6000
Study Start Date: August 2010
Estimated Primary Completion Date: June 2014 (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
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

  Show 69 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:
TOTAL - A Randomized Trial of Routine Aspiration Thrombectomy with Percutaneous Coronary Intervention (PCI) vs. PCI Alone in Patients with STEMI Undergoing Primary PCI (Population Health Research Institute)  This link exits the ClinicalTrials.gov site

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 1, 2013
Health Authority: Canada: Research Ethics Board
United States: Institutional Review Board
Macedonia: Ethics Committee
Brazil: Ethics Committee
China: Ethics Committee
Czech Republic: Ethics Committee
Finland: Ethics Committee
Australia: Ethics Committee
Serbia: Ethics Committee
Greece: Ethics Committee
France: Ethics Committee
Germany: Ethics Committee
Hungary: Ethics Committee
Netherlands: 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 May 16, 2013