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

Last updated: June 11, 2024
Sponsor: Population Health Research Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Stroke

Chest Pain

Cerebral Ischemia

Treatment

Non-vitamin K oral anticoagulant (NOAC)

Clinical Study ID

NCT03968393
2019-ASPIREAF
2023-509142-35-00
2019-001336-62
  • Ages > 55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. an overnight hospital admission after surgery;

  3. day surgery resulting in a large enough physiological insult to be able tocause perioperative AF, as judged by the local investigator

  4. ≥1 episode of clinically important perioperative AF during or after their surgery;

  5. sinus rhythm at the time of randomization; AND

  6. any of the following high-risk criteria:

  7. age 55-64 years, and having either known cardiovascular disease, recent majorvascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponinlevel;

  8. age 65-74 years, and having either known cardiovascular disease, recent majorvascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponinlevel; OR

  9. age ≥75 years.

  10. provide written informed consent

Exclusion

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 nottaking effective contraception; OR

  14. previously enrolled in the trial

Study Design

Total Participants: 2270
Treatment Group(s): 1
Primary Treatment: Non-vitamin K oral anticoagulant (NOAC)
Phase: 4
Study Start date:
June 14, 2019
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Clinica Coronel Suarez

    Coronel Suárez, Buenos Aires 7540
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Clinica San Jorge

    Ushuaia, TDF 9410
    Argentina

    Site Not Available

  • Centro Integral de Arritmias de Tucuman (CIAT)

    San Miguel De Tucumán, Tucuman 4000
    Argentina

    Active - Recruiting

  • Sanatorio 9 de Julio

    San Miguel De Tucumán, Tucuman 4000
    Argentina

    Site Not Available

  • Hospital Municipal Chivilcoy

    Chivilcoy, B6620
    Argentina

    Site Not Available

  • Hospital Privado de Rosario

    Santa Fe, S2000GAP
    Argentina

    Site Not Available

  • Sanatorio Cisma

    Tucuman, T4000
    Argentina

    Active - Recruiting

  • Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Active - Recruiting

  • Bankstown Hospital

    Bankstown, New South Wales 2200
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • John Hunter Hospital

    Newcastle, New South Wales 2305
    Australia

    Active - Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Wollongong Hospital

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • Wesley & Greenscopes Private Hospitals

    Brisbane, Queensland 4064
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Redcliffe Hospital

    Redcliffe, Queensland 4020
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Northeast Health Wangaratta

    Wangaratta, Victoria 3677
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Instituto do Coração do Hospital das Clínicas da FMUSP

    Cerqueira César, 05403-900
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • Foothills Hospital

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Medicine Hat Regional Hospital

    Medicine Hat, Alberta T1A 4H6
    Canada

    Site Not Available

  • East Kootenay Regional Hospital

    Cranbrook, British Columbia V1C 3H9
    Canada

    Site Not Available

  • Fraser Health Authority

    Surrey, British Columbia V3V 1Z2
    Canada

    Active - Recruiting

  • Health Sciences Centre Winnipeg

    Winnipeg, Manitoba R3A 1R9
    Canada

    Active - Recruiting

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

    Moncton, New Brunswick E1C 2Z3
    Canada

    Site Not Available

  • Halifax Infirmary

    Halifax, Nova Scotia B3H 3A6
    Canada

    Active - Recruiting

  • Cape Breton University

    Sydney, Nova Scotia B1M 1A2
    Canada

    Active - Recruiting

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario N1R 6V6
    Canada

    Site Not Available

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • Juravinski Hospital

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

  • Kingston General Hospital

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • London Health Sciences Centre - University Hospital

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • University Hospital

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • The Ottawa Hospital General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Niagara Health System - St. Catharine's Site

    St. Catharines, Ontario L2S 0A9
    Canada

    Active - Recruiting

  • St. Catharines Site - Niagara Health System

    St. Catharines, Ontario L2S 0A9
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec H2X 3E4
    Canada

    Active - Recruiting

  • CHU de Quebec Universite Laval

    Québec, Quebec G1R 2J6
    Canada

    Site Not Available

  • Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec J1H 5H3
    Canada

    Active - Recruiting

  • Regina General Hospital

    Regina, Saskatchewan S4P 0W5
    Canada

    Site Not Available

  • Royal University Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Hospital South West Jutland - University Hospital of Southern Denmark

    Esbjerg, 6700
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

  • Universitatsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • GNRC Medical

    North Guwāhāti, Assam 781031
    India

    Site Not Available

  • Marengo CIMS Hospital

    Ahmedabad, Gujarat 380060
    India

    Site Not Available

  • NU Hospitals

    Bangalore, Karnataka 560010
    India

    Site Not Available

  • Govt. T.D. Medical College

    Alappuzha, Kerala 688005
    India

    Site Not Available

  • Amala Institute

    Thrissur, Kerala 680555
    India

    Site Not Available

  • Jehangir Clinical Development Centre

    Pune, Maharashtra 411001
    India

    Site Not Available

  • Sparsh Hospital

    Bangalore, 560001
    India

    Site Not Available

  • St. John's Medical College Hospital

    Bangalore, 560034
    India

    Active - Recruiting

  • Bangalore Baptist Hospital

    Bengaluru, 560024
    India

    Site Not Available

  • NU Hospitals

    Bengaluru, 560010
    India

    Site Not Available

  • JIPMER

    Pondicherry, 605006
    India

    Active - Recruiting

  • Ruby Hall Clinic

    Pune, 411057
    India

    Site Not Available

  • Trivandrum Medical

    Thiruvananthapuram, 695011
    India

    Site Not Available

  • Government Medical College

    Trivandrum, 695011
    India

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, Milan 20162
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121
    Italy

    Site Not Available

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

    Active - Recruiting

  • La Maddalena

    Palermo, 90146
    Italy

    Active - Recruiting

  • Piacenza Ospedale

    Piacenza, 29121
    Italy

    Active - Recruiting

  • San Luigi Gonzaga

    Turin, 10043
    Italy

    Site Not Available

  • Korea University Ansm Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • B and B Hospital

    Lalitpur, 44700
    Nepal

    Active - Recruiting

  • Jeroen Bosch Hospital

    's-Hertogenbosch, 5223
    Netherlands

    Active - Recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815
    Netherlands

    Active - Recruiting

  • ZiekenhuisGroepTwente (ZGT)

    Almelo, 7609
    Netherlands

    Active - Recruiting

  • Ziekenhuis Amstelland

    Amstelveen, 1186
    Netherlands

    Active - Recruiting

  • Rijnstate Hospital

    Arnhem, 6815
    Netherlands

    Active - Recruiting

  • Deventer Ziekenhuis

    Deventer, 7416
    Netherlands

    Active - Recruiting

  • Hospital Gelderse Vallei

    Ede, 6716
    Netherlands

    Active - Recruiting

  • Martini Hospital

    Groningen, 9728
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis

    Rotterdam, 3045
    Netherlands

    Active - Recruiting

  • Ikazia Hospital

    Rotterdam, 3083
    Netherlands

    Active - Recruiting

  • ETZ Tilburg

    Tilburg, 5022
    Netherlands

    Active - Recruiting

  • Dunedin Public Hospital

    Dunedin, 9016
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3204
    New Zealand

    Site Not Available

  • Aga Khan University

    Karachi, Sindh 74000
    Pakistan

    Active - Recruiting

  • Shifa International Hospital

    Islamabad,
    Pakistan

    Active - Recruiting

  • Dow Medical University

    Karachi,
    Pakistan

    Active - Recruiting

  • Hospital de Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Vall d'Hebron Hospital

    Barcelona, 08014
    Spain

    Site Not Available

  • University Hospital Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitari de Sant Joan

    Reus, 43204
    Spain

    Site Not Available

  • Uppsala University

    Uppsala, 751 85
    Sweden

    Active - Recruiting

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Blackpool Teaching Hospital

    Blackpool, Lancashire FY3 8NR
    United Kingdom

    Site Not Available

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE
    United Kingdom

    Active - Recruiting

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