Back to Trials
NCT03968393PHASE4Recruiting

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

Population Health Research Institute

Start Date

6/14/2019

Completion Date

12/1/2028

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.

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 atrial fibrillation and additional stroke factors occurring transiently with stress. 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

Age Range: 55 years to No maximum

Inclusion Criteria: 1. have ≥1 episode of clinically important AFOTS during any of the following conditions: 1. noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery; 2. noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or 3. acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; 2. sinus rhythm at the time of randomization; 3. 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.; 4. provide written informed consent Exclusion Criteria: 1. any cardiac diagnosis as the primary reason for hospital admission; 2. history of documented chronic AF prior to noncardiac surgery; 3. need for long-term systemic anticoagulation; 4. ongoing need for long-term dual antiplatelet treatment; 5. contraindication to oral anticoagulation; 6. severe renal insufficiency (CrCl \<20 ml/min); 7. severe liver cirrhosis (i.e., Child-Pugh Class C) 8. acute stroke in the past 14 days; 9. underwent cardiac surgery in the past 35 days; 10. history of nontraumatic intracranial, intraocular, or spinal bleeding; 11. hemorrhagic disorder or bleeding diathesis; 12. expected to be non-compliant with follow-up and/or study medications; 13. known life expectancy less than 1 year due to concomitant disease; 14. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR 15. previously enrolled in the trial

Interventions

DRUG

Non-vitamin K oral anticoagulant (NOAC)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

StrokeAtrial Fibrillation

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Mcgovern Medical School at University of Texas

Houston, Texas 77030

United States

Clinica Coronel Suarez

Coronel Suárez, Buenos Aires 7540

Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province 2000

Argentina

Instituto Cardiovascular de Rosario

Rosario, Santa Fe Province S2000

Argentina

Centro Integral de Arritmias de Tucuman (CIAT)

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Hospital Municipal Chivilcoy

Chivilcoy, B6620

Argentina

Sanatorio Cisma

San Miguel de Tucumán, T4000

Argentina

Hospital Privado de Rosario

Santa Fe, S2000GAP

Argentina

Canberra Hospital

Garran, Australian Capital Territory 2605

Australia

Bankstown Hospital

Bankstown, New South Wales 2200

Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Concord Repatriation General Hospital

Concord, New South Wales 2139

Australia

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

John Hunter Hospital

Newcastle, New South Wales 2305

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland 4575

Australia

Royal Brisbane and Women's Hospital

Herston, Queensland 4029

Australia

Redcliffe Hospital

Redcliffe, Queensland 4020

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Box Hill Hospital

Box Hill, Victoria 3128

Australia

Northeast Health Wangaratta

Wangaratta, Victoria 3677

Australia

Royal Perth Hospital

Perth, Western Australia 6000

Australia

Instituto do Coração do Hospital das Clínicas da FMUSP

Cerqueira César, 05403-900

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903

Brazil

Foothills Hospital

Calgary, Alberta T2N 2T9

Canada

University of Alberta Hospital

Edmonton, Alberta T6G 2B7

Canada

Medicine Hat Regional Hospital

Medicine Hat, Alberta T1A 4H6

Canada

East Kootenay Regional Hospital

Cranbrook, British Columbia V1C 3H9

Canada

Fraser Health Authority

Surrey, British Columbia V3V 1Z2

Canada

Vancouver General Hospital

Vancouver, British Columbia V5Z 1N1

Canada

Health Sciences Centre Winnipeg

Winnipeg, Manitoba R3A 1R9

Canada

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

Moncton, New Brunswick E1C 2Z3

Canada

Halifax Infirmary

Halifax, Nova Scotia B3H 3A6

Canada

Cape Breton University

Sydney, Nova Scotia B1M 1A2

Canada

Cambridge Cardiac Care Centre

Cambridge, Ontario N1R 6V6

Canada

Hamilton General Hospital

Hamilton, Ontario L8L 2X2

Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario L8N 4A6

Canada

Juravinski Hospital

Hamilton, Ontario L8V 1C3

Canada

Kingston General Hospital

Kingston, Ontario K7L 2V7

Canada

London Health Sciences Centre - University Hospital

London, Ontario N6A 5A5

Canada

The Ottawa Hospital General Campus

Ottawa, Ontario K1H 8L6

Canada

Niagara Health System - St. Catharine's Site

St. Catharines, Ontario L2S 0A9

Canada

Cortelluci Vaughan Hospital

Vaughan, Ontario L6A 4Z3

Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec H2X 3E4

Canada

CHU de Quebec Universite Laval

Québec, Quebec G1R 2J6

Canada

Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec J1H 5H3

Canada

Regina General Hospital

Regina, Saskatchewan S4P 0W5

Canada

Royal University Hospital

Saskatoon, Saskatchewan S7N 0W8

Canada

Aarhus University Hospital

Aarhus, 8200

Denmark

Hospital South West Jutland - University Hospital of Southern Denmark

Esbjerg, 6700

Denmark

Odense University Hospital

Odense, 5000

Denmark

Southwest Finland Wellbeing County (VARHA)

Turku, 20520

Finland

Universitatsklinikum Leipzig

Leipzig, 04103

Germany

GNRC Medical

North Guwāhāti, Assam 781031

India

Marengo CIMS Hospital

Ahmedabad, Gujarat 380060

India

NU Hospitals

Bangalore, Karnataka 560010

India

Govt. T.D. Medical College

Alappuzha, Kerala 688005

India

Amala Institute of Medical Sciences

Thrissur, Kerala 680555

India

Amala Institute

Thrissur, Kerala 680555

India

St. John's Medical College Hospital

Bangalore, 560034

India

JIPMER

Puducherry, 605006

India

Ruby Hall Clinic

Pune, 411057

India

Trivandrum Medical

Thiruvananthapuram, 695011

India

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milan 20162

Italy

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

Alessandria, 15121

Italy

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

La Maddalena

Palermo, 90146

Italy

Piacenza Ospedale

Piacenza, 29121

Italy

Nobel Medical College Teaching Hospital

Biratnagar, 56700

Nepal

B.P. Koirala Institute of Health Sciences

Koshi, 56700

Nepal

B and B Hospital

Lalitpur, 44700

Nepal

Jeroen Bosch Hospital

's-Hertogenbosch, 5223

Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, 1815

Netherlands

ZiekenhuisGroepTwente (ZGT)

Almelo, 7609

Netherlands

Ziekenhuis Amstelland

Amstelveen, 1186

Netherlands

Rijnstate Hospital

Arnhem, 6815

Netherlands

Amphia Ziekenhuis Breda

Breda, 4818 CK

Netherlands

Deventer Ziekenhuis

Deventer, 7416

Netherlands

Hospital Gelderse Vallei

Ede, 6716

Netherlands

Martini Hospital

Groningen, 9728

Netherlands

Franciscus Gasthuis

Rotterdam, 3045

Netherlands

Ikazia Hospital

Rotterdam, 3083

Netherlands

ETZ Tilburg

Tilburg, 5022

Netherlands

Aga Khan University

Karachi, Sindh 74000

Pakistan

Maroof International Hospital

Islamabad, 04412

Pakistan

Shifa International Hospital

Islamabad,

Pakistan

Dow Medical University

Karachi,

Pakistan

Rehman Medical Institute

Peshawar, 25000

Pakistan

Korea Univesrity Anam Hospital

Seoul, 02841

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Seoul National University Bundang Hospital

Seoul, 13620

South Korea

Hospital de Mar

Barcelona, Barcelona 08003

Spain

Vall d'Hebron Hospital

Barcelona, Barcelona 08014

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025

Spain

Hospital Mutua de Terrassa

Barcelona, 08221

Spain

University Hospital Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario de Navarra

Pamplona, 31008

Spain

Karolinska Institutet Danderyd Hospital

Danderyd, 18257

Sweden

Uppsala University

Uppsala, 751 85

Sweden

University Hospital Basel

Basel, Basel 4031

Switzerland

Kantonsspital St. Gallen

Sankt Gallen, 9000

Switzerland

Kantonsspital Winterthur

Winterthur, 8400

Switzerland

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE

United Kingdom

Southend Hospital

Westcliff-on-Sea, SS0 0RY

United Kingdom