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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 22, 2010

Last Updated Date

October 19, 2015

Start Date ^ICMJE

August 2010

Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01149044 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Stroke [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Cardiovascular Mortality [ Time Frame: up to 180 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Stroke
Device related complications
Major bleeding
Components of primary outcome at 30 days, 180 days and one year

Current Other Outcome Measures ^ICMJE

Primary outcome at 30 days and 1 year [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Components of primary outcome and secondary outcomes [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
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 ] [ 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 ]

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Percutaneous Coronary Intervention

Intervention ^ICMJE

Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

10732

Completion Date

October 2015

Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, 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

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01149044

Other Study ID Numbers ^ICMJE

TOTAL Trial

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Dr. Sanjit S. Jolly, Population Health Research Institute

Study Sponsor ^ICMJE

Population Health Research Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Population Health Research Institute

Verification Date

October 2015

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

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