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

Acute Coronary Syndrome Clinical Trial

— TOTAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149044
• Other study ID #: TOTAL Trial
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: October 19, 2015
• Start date: August 2010
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics BoardUnited States: U.S. Food and Drug Administration, Institutional Review BoardAustralia: Ethics CommitteeAustria: Ethics CommitteeBrazil: Ethics CommitteeBelgium: Ethics CommitteeChina: Ethics CommitteeCzech Republic: Ethics CommitteeFinland: Ethics CommitteeFrance: Ethics CommitteeGermany: Ethics CommitteeGreece: Ethics CommitteeHungary: Ethics CommitteeMacedonia: Ethics CommitteeNetherlands: Ethics CommitteeNew Zealand: Ethics CommitteeSerbia: Ethics CommitteeSouth Korea: Ethics CommitteeSpain: Ethics CommitteeUnited Kingdom: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10732
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

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

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

Locations

Country	Name	City	State
Australia	Gold Coast Hospital	Southport	Queensland
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	St. George Public Hospital	Sydney	New South Wales
Austria	Medical University of Vienna	Vienna
Belgium	CHR de la Citadelle	Lige
Brazil	Hospital Santa Isabel	Blumenau	Santa Catarina
Brazil	Santa Casa de Marilia	Marilia	Sao Paulo
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	RS
Brazil	Hospital Mae de Deus	Porto Elegre
Brazil	Fundação Faculdade de Medicina de São José do Rio Preto	Sao Jose do Rio Preto	Sao Paulo
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Canada	CSSS de Chicoutimi	Chicoutimi	Quebec
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences	Halifax	Nova Scotia
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	MUHC Royal Victoria Hospital	Montreal	Quebec
Canada	York PCI Group - Southlake Regional	Newmarket	Ontario
Canada	Quebec Heart Lung Insitute	Quebec City	Quebec
Canada	Scarborough Cardiology Research	Scarborough	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute	Victoria	British Columbia
Canada	Royal Columbian Hospital	Westminster	British Columbia
China	Shanghai Gongli Hospital	Shanghai
China	The First People's Hospital, Jiatong University	Shanghai
China	The Tenth People's Hospital Tongji University	Shanghai
China	Yueyang Hospital Shanghai University of TCM	Shanghai
Czech Republic	Krasjska Nemocnice Liberec	Liberec
Czech Republic	University Hospital Pilsen	Pilsen
Czech Republic	University Hospital Motol	Prague
Czech Republic	University Hospital Kralovske Vinohrady	Praha
Czech Republic	Masaryk Hospital	Usti nad Labem
Finland	Kuopio University Hospital	Kuopio
Finland	Heart Center, Tampere University Hospital	Tampere
France	Chu Jean Minjoz	Besancon
France	CHU Albert Michallon	Grenoble
France	Hopital Bichat	Paris
France	Hopital Lariboisiere Ap-HP	Paris
France	Centre Hospitalier de Pau	Pau
Germany	Universitatsklinikum Bonn	Bonn
Germany	Elisabeth-Krankenhaus Essen	Essen
Germany	Clinical Association Oberallgaeu-Kempten	Immenstadt
Germany	Klinikum der Universitat Munchen	Munchen
Greece	Patras University Hospital	Patras
Greece	Ahepa University Hospital	Thessaloniki
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Hungary	University of Szeged	Szeged
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Kyung-Hee University Hospital	Seoul
Korea, Republic of	Seoul Boramae Medical Center	Seoul
Macedonia, The Former Yugoslav R	Medical University Skopje	Skopje
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
New Zealand	Waikato Hospital	Hamilton
Serbia	Clinical Center of Serbia	Belgrade
Spain	Hospital Universitari Germans Trias I Pujol	Baldona
Spain	Complexo Hospitalario A Coruna	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	University Hospital La Paz	Madrid
Spain	Hospital Son Espases	Palma de Mallorca
Spain	Hospital Clinico Universitario de Vigo	Vigo
United Kingdom	Hampshire Hospitals NHS Fuondation Trust	Basingstoke
United Kingdom	Barts and The London Heart and Chest Centre	Bethnal Green
United Kingdom	Frimley Park Hospital, NHS Foundation Trust	Camberley
United Kingdom	Hull and East Yorkshire Hospitals	Hull
United Kingdom	Kettering General Hospital	Kettering
United Kingdom	Glenfield General Hospital	Leicester
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	University Hospital South Manchester	Manchester
United Kingdom	Queen Elizabeth the Queen Mother Hospital	Margate
United Kingdom	Sheffield Teaching Hospitals	Sheffield
United Kingdom	University Hospital Southampton	Southampton
United Kingdom	Musgrove Park Hospital	Taunton
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Central Cardiology medical Clinic	Bakersfield	California
United States	Lindner Research Center at Christ Hospital	Cincinnati	Ohio
United States	Geisinger Clinic	Danville	Pennsylvania
United States	WPAHS - Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Northeast Clinical Trials Group	Scranton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Countries where clinical trial is conducted

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, 

References & Publications (2)

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. — View Citation

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, Bhin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary outcome at 30 days and 1 year		up to 1 year	No
Other	Components of primary outcome and secondary outcomes	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	up to 1 year	No
Other	All-cause mortality	All-cause mortality at 30 days, 180 days and 1 year	up to 1 year	No
Other	Composite of CV death, MI, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days	Composite of cardiovascular death, myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days	up to 180 days	No
Other	TIMI flow rates, no reflow		up to 1 year	No
Other	Stent thrombosis		up to 1 year	No
Other	Distal embolization		up to 1 year	No
Other	Left main thrombus as a complication of the PCI procedure		up to 1 year	No
Other	Target Vessel dissection		up to 1 year	No
Other	Left main dissection		up to 1 year	No
Other	Major Bleeding		up to 1 year	No
Primary	The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure		up to 180 days	No
Secondary	Stroke		up to 30 days	Yes
Secondary	Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure		up to 1 year	Yes
Secondary	Cardiovascular Mortality		up to 180 days	No
Secondary	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		up to 180 days	No

External Links

•   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)