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)

Tracking Information
First Submitted Date ICMJE	June 22, 2010
First Posted Date ICMJE	June 23, 2010
Last Update Posted Date	October 20, 2015
Study Start Date ICMJE	August 2010
Actual Primary Completion Date	March 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 27, 2012)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: June 22, 2010)	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 ]
Change History	Complete list of historical versions of study NCT01149044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 22, 2013)	Stroke [ Time Frame: up to 30 days ]; 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 ]; Cardiovascular Mortality [ Time Frame: up to 180 days ]; 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 ]
Original Secondary Outcome Measures ICMJE; (submitted: June 22, 2010)	Stroke; Device related complications; Major bleeding; Components of primary outcome at 30 days, 180 days and one year
Current Other Outcome Measures ICMJE; (submitted: October 22, 2013)	Primary outcome at 30 days and 1 year [ Time Frame: up to 1 year ]; 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; All-cause mortality [ Time Frame: up to 1 year ]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 ]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 ]; Stent thrombosis [ Time Frame: up to 1 year ]; Distal embolization [ Time Frame: up to 1 year ]; Left main thrombus as a complication of the PCI procedure [ Time Frame: up to 1 year ]; Target Vessel dissection [ Time Frame: up to 1 year ]; Left main dissection [ Time Frame: up to 1 year ]; Major Bleeding [ Time Frame: up to 1 year ]
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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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 *	Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemelä 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, Džavík 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, Niemelä 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, Džavík 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.; Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemelä 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, Džavík 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, Džavík 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.
* 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
Actual Enrollment ICMJE; (submitted: December 11, 2014)	10732
Original Estimated Enrollment ICMJE; (submitted: June 22, 2010)	4000
Actual Study Completion Date	October 2015
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	19 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	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, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01149044
Other Study ID Numbers ICMJE	TOTAL Trial
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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