RecruitingPhase 4NCT03968393

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial

Sponsor

Population Health Research Institute

Enrollment

2,270 participants

Start Date

Jun 14, 2019

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Stroke

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 atrial fibrillation occurring transiently with stress and additional stroke risk factors.

Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether taking blood-thinning medication (anticoagulation) after a temporary episode of atrial fibrillation (irregular heartbeat) during surgery or illness can help prevent strokes. You may be eligible if... - You had at least one episode of atrial fibrillation during noncardiac surgery or a serious medical illness in the past 35 days - You are currently in normal heart rhythm - You are in a higher-risk age group with additional heart or vascular risk factors You may NOT be eligible if... - Your heart condition was the main reason for your hospital stay - You have a history of chronic atrial fibrillation before surgery - You need long-term blood thinners or dual antiplatelet therapy for another reason - You had a stroke in the past 14 days, or have severe kidney or liver disease - You are pregnant, breastfeeding, or not using effective birth control Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNon-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(105)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Mcgovern Medical School at University of Texas

Houston, Texas, United States

Clinica Coronel Suarez

Coronel Suárez, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

Instituto Cardiovascular de Rosario

Rosario, Santa Fe Province, Argentina

Centro Integral de Arritmias de Tucuman (CIAT)

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Municipal Chivilcoy

Chivilcoy, Argentina

Sanatorio Cisma

San Miguel de Tucumán, Argentina

Hospital Privado de Rosario

Santa Fe, Argentina

Canberra Hospital

Garran, Australian Capital Territory, Australia

Bankstown Hospital

Bankstown, New South Wales, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

Newcastle, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Redcliffe Hospital

Redcliffe, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Northeast Health Wangaratta

Wangaratta, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Instituto do Coração do Hospital das Clínicas da FMUSP

Cerqueira César, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Foothills Hospital

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Medicine Hat Regional Hospital

Medicine Hat, Alberta, Canada

East Kootenay Regional Hospital

Cranbrook, British Columbia, Canada

Fraser Health Authority

Surrey, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

Dr.-Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, Canada

Halifax Infirmary

Halifax, Nova Scotia, Canada

Cape Breton University

Sydney, Nova Scotia, Canada

Cambridge Cardiac Care Centre

Cambridge, Ontario, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Juravinski Hospital

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre - University Hospital

London, Ontario, Canada

The Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Niagara Health System - St. Catharine's Site

St. Catharines, Ontario, Canada

Cortelluci Vaughan Hospital

Vaughan, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

CHU de Quebec Universite Laval

Québec, Quebec, Canada

Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Regina General Hospital

Regina, Saskatchewan, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Aarhus University Hospital

Aarhus, Denmark

Hospital South West Jutland - University Hospital of Southern Denmark

Esbjerg, Denmark

Odense University Hospital

Odense, Denmark

Southwest Finland Wellbeing County (VARHA)

Turku, Finland

Universitatsklinikum Leipzig

Leipzig, Germany

GNRC Medical

North Guwāhāti, Assam, India

Marengo CIMS Hospital

Ahmedabad, Gujarat, India

NU Hospitals

Bangalore, Karnataka, India

Govt. T.D. Medical College

Alappuzha, Kerala, India

Amala Institute of Medical Sciences

Thrissur, Kerala, India

Amala Institute

Thrissur, Kerala, India

St. John's Medical College Hospital

Bangalore, India

JIPMER

Puducherry, India

Ruby Hall Clinic

Pune, India

Trivandrum Medical

Thiruvananthapuram, India

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milan, Italy

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milan, Italy

La Maddalena

Palermo, Italy

Piacenza Ospedale

Piacenza, Italy

Nobel Medical College Teaching Hospital

Biratnagar, Nepal

B.P. Koirala Institute of Health Sciences

Koshi, Nepal

B and B Hospital

Lalitpur, Nepal

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

ZiekenhuisGroepTwente (ZGT)

Almelo, Netherlands

Ziekenhuis Amstelland

Amstelveen, Netherlands

Rijnstate Hospital

Arnhem, Netherlands

Amphia Ziekenhuis Breda

Breda, 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, Netherlands

Aga Khan University

Karachi, Sindh, Pakistan

Maroof International Hospital

Islamabad, Pakistan

Shifa International Hospital

Islamabad, Pakistan

Dow Medical University

Karachi, Pakistan

Rehman Medical Institute

Peshawar, Pakistan

Korea Univesrity Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea

Hospital de Mar

Barcelona, Barcelona, Spain

Vall d'Hebron Hospital

Barcelona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Mutua de Terrassa

Barcelona, Spain

University Hospital Ramon y Cajal

Madrid, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Karolinska Institutet Danderyd Hospital

Danderyd, Sweden

Uppsala University

Uppsala, Sweden

University Hospital Basel

Basel, Basel, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Southend Hospital

Westcliff-on-Sea, United Kingdom

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NCT03968393

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