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 - Full Text View

Purpose

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.

Condition	Intervention
Acute Coronary Syndrome ST Elevation Myocardial Infarction Percutaneous Coronary Intervention	Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Dr. Sanjit S. Jolly, Population Health Research Institute:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Other Outcome Measures:

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 ]


Enrollment:	10732
Study Start Date:	August 2010
Study Completion Date:	October 2015
Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Upfront Thrombectomy followed by PCI Upfront manual aspiration thrombectomy followed by PCI	Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
Active Comparator: PCI Alone PCI without upfront manual aspiration thrombectomy	Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

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.

Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149044

Show 87 Study Locations

Sponsors and Collaborators

Population Health Research Institute

Investigators


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

More Information

Additional Information:

TOTAL - A Randomized Trial of Routine Aspiration Thrombectomy with Percutaneous Coronary Intervention (PCI) vs. PCI Alone in Patients with STEMI Undergoing Primary PCI (Population Health Research Institute) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Dr. Sanjit S. Jolly, MD MSc, FRCP(C), Interventional Cardiologist, Assistant Professor, Population Health Research Institute
ClinicalTrials.gov Identifier:	NCT01149044 History of Changes
Other Study ID Numbers:	TOTAL Trial
Study First Received:	June 22, 2010
Last Updated:	October 19, 2015

Keywords provided by Dr. Sanjit S. Jolly, Population Health Research Institute:


Acute Coronary Syndrome PCI Percutaneous Coronary Intervention STEMI Thrombectomy

Additional relevant MeSH terms:


Infarction Myocardial Infarction Acute Coronary Syndrome Ischemia Pathologic Processes	Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on July 13, 2017

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)