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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI
Secondary ID [1] 0 0
TOTAL Trial
Universal Trial Number (UTN)
Trial acronym
TOTAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
ST Elevation Myocardial Infarction 0 0
Percutaneous Coronary Intervention 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Upfront Thrombectomy followed by PCI - Upfront manual aspiration thrombectomy followed by PCI

Active comparator: PCI Alone - PCI without upfront manual aspiration thrombectomy
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure
Timepoint [1] 0 0
up to 180 days
Secondary outcome [1] 0 0
Stroke
Timepoint [1] 0 0
up to 30 days
Secondary outcome [2] 0 0
Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure
Timepoint [2] 0 0
up to 1 year
Secondary outcome [3] 0 0
Cardiovascular Mortality
Timepoint [3] 0 0
up to 180 days
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
up to 180 days

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
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
10732
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [2] 0 0
St. George Public Hospital - Sydney
Recruitment hospital [3] 0 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Austria
State/province [6] 0 0
Vienna
Country [7] 0 0
Belgium
State/province [7] 0 0
Lige
Country [8] 0 0
Brazil
State/province [8] 0 0
RS
Country [9] 0 0
Brazil
State/province [9] 0 0
Santa Catarina
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Brazil
State/province [11] 0 0
Porto Elegre
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Nova Scotia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
China
State/province [17] 0 0
Shanghai
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Liberec
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Pilsen
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Prague
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Praha
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Usti nad Labem
Country [23] 0 0
Finland
State/province [23] 0 0
Kuopio
Country [24] 0 0
Finland
State/province [24] 0 0
Tampere
Country [25] 0 0
France
State/province [25] 0 0
Besancon
Country [26] 0 0
France
State/province [26] 0 0
Grenoble
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pau
Country [29] 0 0
Germany
State/province [29] 0 0
Bonn
Country [30] 0 0
Germany
State/province [30] 0 0
Essen
Country [31] 0 0
Germany
State/province [31] 0 0
Immenstadt
Country [32] 0 0
Germany
State/province [32] 0 0
Munchen
Country [33] 0 0
Greece
State/province [33] 0 0
Patras
Country [34] 0 0
Greece
State/province [34] 0 0
Thessaloniki
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Szeged
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Cheonan
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Gwangju
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul
Country [40] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [40] 0 0
Skopje
Country [41] 0 0
Netherlands
State/province [41] 0 0
Nieuwegein
Country [42] 0 0
New Zealand
State/province [42] 0 0
Hamilton
Country [43] 0 0
Serbia
State/province [43] 0 0
Belgrade
Country [44] 0 0
Spain
State/province [44] 0 0
Baldona
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Palma de Mallorca
Country [48] 0 0
Spain
State/province [48] 0 0
Vigo
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Basingstoke
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Bethnal Green
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Camberley
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Hull
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Kettering
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Leicester
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Manchester
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Margate
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Sheffield
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Southampton
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01149044
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.
Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.
Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, Cantor WJ, Overgaard CB, Lavi S, Sharma V, Chowdhary S, Stankovic G, Kedev S, Bernat I, Bhindi R, Sheth T, Niemela K, Jolly SS, Dzavik V. Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011336. doi: 10.1161/CIRCINTERVENTIONS.121.011336. Epub 2022 May 17.
Moxham R, Dzavik V, Cairns J, Natarajan MK, Bainey KR, Akl E, Tsang MB, Lavi S, Cantor WJ, Madan M, Liu YY, Jolly SS. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial. JAMA Netw Open. 2021 Mar 1;4(3):e213505. doi: 10.1001/jamanetworkopen.2021.3505.
Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Dzavik V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.
Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemela K, Natarajan MK, Shestakovska O, Tittarelli R, Meeks B, Jolly SS. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial. Circ Cardiovasc Interv. 2016 Apr;9(4):e003414. doi: 10.1161/CIRCINTERVENTIONS.115.003414.
Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Dzavik V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22.
Jolly SS, Cairns JA, Yusuf S, Meeks B, Gao P, Hart RG, Kedev S, Stankovic G, Moreno R, Horak D, Kassam S, Rokoss MJ, Leung RC, El-Omar M, Romppanen HO, Alazzoni A, Alak A, Fung A, Alexopoulos D, Schwalm JD, Valettas N, Dzavik V; TOTAL Investigators. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. Eur Heart J. 2015 Sep 14;36(35):2364-72. doi: 10.1093/eurheartj/ehv296. Epub 2015 Jun 29.
Williams PD, Mamas MA, Fraser DG. A coronary artery cast. Can J Cardiol. 2011 Nov-Dec;27(6):871.e5-6. doi: 10.1016/j.cjca.2011.08.108. Epub 2011 Oct 14. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
Sanjit S. Jolly, MD, MSc, FRCP
Address 0 0
Hamilton Health Sciences Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01149044