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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01149044
Registration number
NCT01149044
Ethics application status
Date submitted
22/06/2010
Date registered
23/06/2010
Date last updated
20/10/2015
Titles & IDs
Public title
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
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Scientific title
TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI
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Secondary ID [1]
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TOTAL Trial
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Universal Trial Number (UTN)
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Trial acronym
TOTAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome
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ST Elevation Myocardial Infarction
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Percutaneous Coronary Intervention
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
Active Comparator: Upfront Thrombectomy followed by PCI - Upfront manual aspiration thrombectomy followed by PCI
Active Comparator: PCI Alone - PCI without upfront manual aspiration thrombectomy
Treatment: Surgery: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure
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Assessment method [1]
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Timepoint [1]
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up to 180 days
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Secondary outcome [1]
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Stroke
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Assessment method [1]
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Timepoint [1]
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up to 30 days
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Secondary outcome [2]
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Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure
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Assessment method [2]
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Timepoint [2]
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up to 1 year
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Secondary outcome [3]
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Cardiovascular Mortality
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Assessment method [3]
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Timepoint [3]
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up to 180 days
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Secondary outcome [4]
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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
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Assessment method [4]
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Timepoint [4]
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up to 180 days
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Eligibility
Key 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
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Minimum age
19
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2015
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Sample size
Target
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Accrual to date
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Final
10732
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Royal North Shore Hospital - Sydney
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St. George Public Hospital - Sydney
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Gold Coast Hospital - Southport
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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- Southport
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Recruitment outside Australia
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United States of America
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California
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Georgia
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Vienna
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Lige
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RS
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Brazil
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Santa Catarina
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Brazil
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Brazil
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Alberta
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Liberec
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France
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Essen
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Germany
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Hull
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Southampton
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Taunton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Population Health Research Institute
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01149044
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Trial related presentations / publications
Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemela K, Steg PG, Bertrand OF, Rao SV, Avezum A, Cantor WJ, Pancholy SB, Moreno R, Gershlick A, Bhindi R, Welsh RC, Cheema AN, Lavi S, Rokoss M, Dzavik V. Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI. Am Heart J. 2014 Mar;167(3):315-321.e1. doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.
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Public notes
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Contacts
Principal investigator
Name
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Sanjit S. Jolly, MD, MSc, FRCP
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Address
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Hamilton Health Sciences Corporation
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01149044
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