Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

Stroke Clinical Trial

— ASPIRE-AF  

Official title:

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968393
• Other study ID #: 2019-ASPIREAF
• Secondary ID: 2019-001336-6220
• Status: Recruiting
• Phase: Phase 4
• Start date: June 14, 2019
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Population Health Research Institute
• Contact: Cassie McDonald
• Phone: 1-905-594-0560
• Email: aspireaf[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2270
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Drug:
• Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.

Locations

Country	Name	City	State
Argentina	Hospital Municipal Chivilcoy	Chivilcoy
Argentina	Clinica Coronel Suarez	Coronel Suárez	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas Rosario	Rosario	Santa Fe
Argentina	Centro Integral de Arritmias de Tucuman (CIAT)	San Miguel De Tucumán	Tucuman
Argentina	Sanatorio 9 de Julio	San Miguel De Tucumán	Tucuman
Argentina	Hospital Privado de Rosario	Santa Fe
Argentina	Sanatorio Cisma	Tucuman
Argentina	Clinica San Jorge	Ushuaia	TDF
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Bankstown Hospital	Bankstown	New South Wales
Australia	Sunshine Coast Hospital and Health Service	Birtinya	Queensland
Australia	Wesley & Greenscopes Private Hospitals	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Canberra Hospital	Garran	Australian Capital Territory
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Redcliffe Hospital	Redcliffe	Queensland
Australia	Northeast Health Wangaratta	Wangaratta	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Wollongong Hospital	Wollongong	New South Wales
Brazil	Instituto do Coração do Hospital das Clínicas da FMUSP	Cerqueira César
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre
Canada	Foothills Hospital	Calgary	Alberta
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	East Kootenay Regional Hospital	Cranbrook	British Columbia
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Halifax Infirmary	Halifax	Nova Scotia
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	Medicine Hat Regional Hospital	Medicine Hat	Alberta
Canada	Dr.-Georges-L.-Dumont University Hospital Centre	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	The Ottawa Hospital General Campus	Ottawa	Ontario
Canada	CHU de Quebec Universite Laval	Québec	Quebec
Canada	Regina General Hospital	Regina	Saskatchewan
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Niagara Health System - St. Catharine's Site	St. Catharines	Ontario
Canada	Fraser Health Authority	Surrey	British Columbia
Canada	Cape Breton University	Sydney	Nova Scotia
Canada	Health Sciences Centre Winnipeg	Winnipeg	Manitoba
Denmark	Aarhus University Hospital	Aarhus
Denmark	Hospital South West Jutland - University Hospital of Southern Denmark	Esbjerg
Denmark	Odense University Hospital	Odense
Germany	Universitatsklinikum Leipzig	Leipzig
India	Marengo CIMS Hospital	Ahmedabad	Gujarat
India	Govt. T.D. Medical College	Alappuzha	Kerala
India	NU Hospitals	Bangalore	Karnataka
India	St. John's Medical College Hospital	Bangalore
India	Bangalore Baptist Hospital	Bengaluru
India	GNRC Medical	North Guwahati	Assam
India	JIPMER	Pondicherry
India	Ruby Hall Clinic	Pune
India	Trivandrum Medical	Thiruvananthapuram
India	Amala Institute	Thrissur	Kerala
Italy	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico	Milan
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano	Milan
Italy	La Maddalena	Palermo
Italy	Piacenza Ospedale	Piacenza
Korea, Republic of	Korea University Ansm Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Nepal	B and B Hospital	Lalitpur
Netherlands	Jeroen Bosch Hospital	's-Hertogenbosch
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	ZiekenhuisGroepTwente (ZGT)	Almelo
Netherlands	Ziekenhuis Amstelland	Amstelveen
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Hospital Gelderse Vallei	Ede
Netherlands	Martini Hospital	Groningen
Netherlands	Franciscus Gasthuis	Rotterdam
Netherlands	Ikazia Hospital	Rotterdam
Netherlands	ETZ Tilburg	Tilburg
New Zealand	Dunedin Public Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
Pakistan	Shifa International Hospital	Islamabad
Pakistan	Aga Khan University	Karachi	Sindh
Pakistan	Dow Medical University	Karachi
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital de Mar	Barcelona
Spain	Vall d'Hebron Hospital	Barcelona
Spain	University Hospital Ramon y Cajal	Madrid
Sweden	Uppsala University	Uppsala
Switzerland	University Hospital Basel	Basel
United Kingdom	Blackpool Teaching Hospital	Blackpool	Lancashire
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Canada,  Denmark,  Germany,  India,  Italy,  Korea, Republic of,  Nepal,  Netherlands,  New Zealand,  Pakistan,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of composite of life-threatening, major, and critical organ bleeding	Safety objective, measured as previously done in the MANAGE trial	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Other	Incidence of major bleeding	Safety objective, measured according to the ISTH criteria	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Other	Incidence of hemorrhagic stroke	Safety objective	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Other	Hospitalization for vascular causes	Tertiary Objective	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Other	Hospitalization for all causes	Tertiary Objective	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Primary	Incidence of Non-hemorrhagic stroke or systemic embolism		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Primary	Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of vascular mortality		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of non-fatal, non-hemorrhagic stroke		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of Myocardial infarction		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of peripheral arterial thrombosis		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of amputation		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of symptomatic venous thromboembolism		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of all-cause stroke		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Secondary	Incidence of all-cause mortality		For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)