Clinical trial NCT03968393: Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery
Official title: Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Stroke
Atrial Fibrillation
Keywords: Transient Atrial Fibrillation
Perioperative Atrial Fibrillation
Non-vitamin K Oral Anticoagulation
Noncardiac Surgery
PROBE Design
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2019-05-30
Enrollment: 2270
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open-label clinical trial with blinded outcome assessment
Primary purpose: PREVENTION

Brief summary: Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

Detailed description: ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Eligibility criteria: Inclusion Criteria:

1. noncardiac surgery in the past 35 days with at least one of the following:

   1. an overnight hospital admission after surgery;
   2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator
2. ≥1 episode of clinically important perioperative AF during or after their surgery;
3. sinus rhythm at the time of randomization; AND
4. any of the following high-risk criteria:

   1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
   2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
   3. age ≥75 years.
5. provide written informed consent

Exclusion Criteria:

1. history of documented chronic AF prior to noncardiac surgery;
2. need for long-term systemic anticoagulation;
3. ongoing need for long-term dual antiplatelet treatment;
4. contraindication to oral anticoagulation;
5. severe renal insufficiency (CrCl \<20 ml/min);
6. severe liver cirrhosis (i.e., Child-Pugh Class C)
7. acute stroke in the past 14 days;
8. underwent cardiac surgery in the past 35 days;
9. history of nontraumatic intracranial, intraocular, or spinal bleeding;
10. hemorrhagic disorder or bleeding diathesis;
11. expected to be non-compliant with follow-up and/or study medications;
12. known life expectancy less than 1 year due to concomitant disease;
13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
14. previously enrolled in the trial

Primary outcomes:
measure: Incidence of Non-hemorrhagic stroke or systemic embolism
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary outcomes:
measure: Incidence of vascular mortality
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of non-fatal, non-hemorrhagic stroke
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of Myocardial infarction
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of peripheral arterial thrombosis
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of amputation
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of symptomatic venous thromboembolism
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of all-cause stroke
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of all-cause mortality
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Other outcomes:
measure: Incidence of composite of life-threatening, major, and critical organ bleeding
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of major bleeding
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Incidence of hemorrhagic stroke
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Hospitalization for vascular causes
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
measure: Hospitalization for all causes
timeFrame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Houston
country: United States
facility: Mcgovern Medical School at University of Texas
state: Texas
city: Coronel Suárez
country: Argentina
facility: Clinica Coronel Suarez
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Cardiovascular de Rosario
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Centro Integral de Arritmias de Tucuman (CIAT)
state: Tucuman
city: Chivilcoy
country: Argentina
facility: Hospital Municipal Chivilcoy
city: Santa Fe
country: Argentina
facility: Hospital Privado de Rosario
city: Tucuman
country: Argentina
facility: Sanatorio Cisma
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Bankstown
country: Australia
facility: Bankstown Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast Hospital and Health Service
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Wangaratta
country: Australia
facility: Northeast Health Wangaratta
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Cerqueira César
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da FMUSP
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Medicine Hat
country: Canada
facility: Medicine Hat Regional Hospital
state: Alberta
city: Cranbrook
country: Canada
facility: East Kootenay Regional Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Health Authority
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre Winnipeg
state: Manitoba
city: Moncton
country: Canada
facility: Dr.-Georges-L.-Dumont University Hospital Centre
state: New Brunswick
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton University
state: Nova Scotia
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System - St. Catharine's Site
state: Ontario
city: Vaughan
country: Canada
facility: Cortelluci Vaughan Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec Universite Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Esbjerg
country: Denmark
facility: Hospital South West Jutland - University Hospital of Southern Denmark
city: Odense
country: Denmark
facility: Odense University Hospital
city: Turku
country: Finland
facility: Southwest Finland Wellbeing County (VARHA)
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: North Guwāhāti
country: India
facility: GNRC Medical
state: Assam
city: Ahmedabad
country: India
facility: Marengo CIMS Hospital
state: Gujarat
city: Bangalore
country: India
facility: NU Hospitals
state: Karnataka
city: Alappuzha
country: India
facility: Govt. T.D. Medical College
state: Kerala
city: Thrissur
country: India
facility: Amala Institute of Medical Sciences
state: Kerala
city: Thrissur
country: India
facility: Amala Institute
state: Kerala
city: Bangalore
country: India
facility: St. John's Medical College Hospital
city: Pondicherry
country: India
facility: JIPMER
city: Pune
country: India
facility: Ruby Hall Clinic
city: Thiruvananthapuram
country: India
facility: Trivandrum Medical
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Milan
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: La Maddalena
city: Piacenza
country: Italy
facility: Piacenza Ospedale
city: Seoul
country: Korea, Republic of
facility: Korea Univesrity Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Biratnagar
country: Nepal
facility: Nobel Medical College Teaching Hospital
city: Koshi
country: Nepal
facility: B.P. Koirala Institute of Health Sciences
city: Lalitpur
country: Nepal
facility: B and B Hospital
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Almelo
country: Netherlands
facility: ZiekenhuisGroepTwente (ZGT)
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Breda
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Ede
country: Netherlands
facility: Hospital Gelderse Vallei
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
city: Tilburg
country: Netherlands
facility: ETZ Tilburg
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
city: Islamabad
country: Pakistan
facility: Maroof International Hospital
city: Islamabad
country: Pakistan
facility: Shifa International Hospital
city: Karachi
country: Pakistan
facility: Dow Medical University
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute
city: Barcelona
country: Spain
facility: Hospital de Mar
city: Barcelona
country: Spain
facility: Vall d'Hebron Hospital
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Mutua de Terrassa
city: Madrid
country: Spain
facility: University Hospital Ramon y Cajal
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Danderyd
country: Sweden
facility: Karolinska Institutet Danderyd Hospital
city: Uppsala
country: Sweden
facility: Uppsala University
city: Basel
country: Switzerland
facility: University Hospital Basel
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Westcliff-on-Sea
country: United Kingdom
facility: Southend Hospital
Study officials:
affiliation: Population Health Research Institute
name: David Conen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: PJ Devereaux, MD, PhD
role: STUDY_CHAIR
References: