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Completed

NCT Number: NCT01149044

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention ST Elevation Myocardial Infarction Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal North Shore Hospital, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Referred for primary PCI
  • Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
  • Informed consent

Exclusion criteria

  • Age ≤ 18 years
  • Prior coronary artery bypass surgery (CABG)
  • Life expectancy less than six months due to non-cardiac condition
  • Treatment with fibrinolytic therapy for qualifying index STEMI event

Treatment and study plan

Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

Procedure

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

Acronym: TOTAL

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2010
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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