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出境医 / 临床实验 / Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery (ASPIRE-AF)

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

Study Description
Brief Summary:
Pilot 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.

Condition or disease Intervention/treatment Phase
Stroke Atrial Fibrillation Drug: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily, Dabigatran 110mg twice daily, or, Rivaroxaban 20mg daily. Phase 3

Detailed Description:
ASPIRE-AF is a prospective, randomized, open-label trial to assess the feasibility of a randomized controlled trial of non-vitamin K oral anticoagulants (NOACs) versus no anticoagulation in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors. The primary objective is to assess the feasibility of a randomized controlled trial of NOACs versus no anticoagulation in patients with perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open-label clinical trial with blinded outcome assessment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Pilot Study
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Non-vitamin K oral anticoagulant (NOAC) Drug: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily, Dabigatran 110mg twice daily, or, Rivaroxaban 20mg daily.
Daily administration from time of randomization to final follow-up
No Intervention: No anticoagulation
Patients allocated to the no anticoagulation arm are not allowed to receive oral anticoagulation, unless the patient develops an indication for its use during follow-up.
Outcome Measures
Primary Outcome Measures :
  1. Number of Participants to Complete Recruitment [ Time Frame: Up to 24 months, until final follow-up ]
    Recruit 100 patients at an average recruitment rate of 1 patient per centre per month

  2. Number of Participants to Complete Follow-up [ Time Frame: Up to 24 months, until final follow-up ]
    Achieve complete follow-up on 90% more of patients

  3. Total Resource Requirement [ Time Frame: Up to 24 months, until final follow-up ]
    Determine resource requirements to achieve recruitment and follow-up goals

  4. Rate of Drug Adherence [ Time Frame: Up to 24 months, until final follow-up ]
    Determine feasibility of administering oral anticoagulation


Secondary Outcome Measures :
  1. Incidence of Non-hemorrhagic stroke or systemic embolism [ Time Frame: Up to 24 months, until final follow-up ]
  2. Incidence of All-cause mortality [ Time Frame: Up to 24 months, until final follow-up ]
  3. Incidence of Vascular mortality [ Time Frame: Up to 24 months, until final follow-up ]
  4. Incidence of Myocardial infarction [ Time Frame: Up to 24 months, until final follow-up ]
  5. Incidence of Symptomatic venous thromboembolism [ Time Frame: Up to 24 months, until final follow-up ]
  6. Incidence of Hospitalization for congestive heart failure [ Time Frame: Up to 24 months, until final follow-up ]

Other Outcome Measures:
  1. Tertiary objective: Montreal Cognitive Assessment [ Time Frame: Baseline, 1 year (if applicable), final follow-up ]
    Effects of NOACs on the change in Montreal Cognitive Assessment scores (range between 0-30 points)

  2. Safety objective: incidence of composite of life-threatening, major, and critical organ bleeding [ Time Frame: Up to 24 months, until final follow-up ]
    as previously used in the MANAGE trial

  3. Safety objective: incidence of major bleeding [ Time Frame: Up to 24 months, until final follow-up ]
    According to the ISTH criteria

  4. Safety objective: incidence of hemorrhagic stroke [ Time Frame: Up to 24 months, until final follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
  2. ≥1 episode of clinically significant perioperative AF;
  3. sinus rhythm at the time of randomization; AND

  4. any of the following high-risk criteria:

    1. age ≥55 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score ≥3;
    2. age ≥65 and a CHA2DS2VASc score**** ≥2; OR
    3. age ≥75 years.

Exclusion Criteria:

  1. history of documented 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 (eGFR <30 ml/min);
  6. acute stroke in the past 3 months;
  7. underwent cardiac surgery in the past 3 months;
  8. history of intracranial, intraocular, or spinal bleeding;
  9. hemorrhagic disorder or bleeding diathesis;
  10. expected to be non-compliant with follow-up and/or study medications;
  11. known life expectancy less than 1 year due to concomitant disease;
  12. women who are pregnant, breastfeeding, or of childbearing potential; OR
  13. previously enrolled in the trial
Contacts and Locations

Contacts
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Contact: Jennifer Wells 905-297-3479 ext 41133 aspireaf@phri.ca

Locations
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Canada, Alberta
University of Alberta Hospital Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
St Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Juravinski Hospital Recruiting
Hamilton, Ontario, Canada, L8V 1C3
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 5W9
Canada, Quebec
Centre hospitalier de l'Université de Montréal Not yet recruiting
Montréal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Population Health Research Institute
Investigators
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Principal Investigator: David Conen, MD, MPH Population Health Research Institute
Study Chair: PJ Devereaux, MD, PhD Population Health Research Institute
Tracking Information
First Submitted Date  ICMJE March 22, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE June 14, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Number of Participants to Complete Recruitment [ Time Frame: Up to 24 months, until final follow-up ]
    Recruit 100 patients at an average recruitment rate of 1 patient per centre per month
  • Number of Participants to Complete Follow-up [ Time Frame: Up to 24 months, until final follow-up ]
    Achieve complete follow-up on 90% more of patients
  • Total Resource Requirement [ Time Frame: Up to 24 months, until final follow-up ]
    Determine resource requirements to achieve recruitment and follow-up goals
  • Rate of Drug Adherence [ Time Frame: Up to 24 months, until final follow-up ]
    Determine feasibility of administering oral anticoagulation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Incidence of Non-hemorrhagic stroke or systemic embolism [ Time Frame: Up to 24 months, until final follow-up ]
  • Incidence of All-cause mortality [ Time Frame: Up to 24 months, until final follow-up ]
  • Incidence of Vascular mortality [ Time Frame: Up to 24 months, until final follow-up ]
  • Incidence of Myocardial infarction [ Time Frame: Up to 24 months, until final follow-up ]
  • Incidence of Symptomatic venous thromboembolism [ Time Frame: Up to 24 months, until final follow-up ]
  • Incidence of Hospitalization for congestive heart failure [ Time Frame: Up to 24 months, until final follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 27, 2019)
  • Tertiary objective: Montreal Cognitive Assessment [ Time Frame: Baseline, 1 year (if applicable), final follow-up ]
    Effects of NOACs on the change in Montreal Cognitive Assessment scores (range between 0-30 points)
  • Safety objective: incidence of composite of life-threatening, major, and critical organ bleeding [ Time Frame: Up to 24 months, until final follow-up ]
    as previously used in the MANAGE trial
  • Safety objective: incidence of major bleeding [ Time Frame: Up to 24 months, until final follow-up ]
    According to the ISTH criteria
  • Safety objective: incidence of hemorrhagic stroke [ Time Frame: Up to 24 months, until final follow-up ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery
Official Title  ICMJE Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Pilot Study
Brief Summary Pilot 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 to assess the feasibility of a randomized controlled trial of non-vitamin K oral anticoagulants (NOACs) versus no anticoagulation in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors. The primary objective is to assess the feasibility of a randomized controlled trial of NOACs versus no anticoagulation in patients with perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, randomized, open-label clinical trial with blinded outcome assessment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Stroke
  • Atrial Fibrillation
Intervention  ICMJE Drug: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily, Dabigatran 110mg twice daily, or, Rivaroxaban 20mg daily.
Daily administration from time of randomization to final follow-up
Study Arms  ICMJE
  • Experimental: Non-vitamin K oral anticoagulant (NOAC)
    Intervention: Drug: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily, Dabigatran 110mg twice daily, or, Rivaroxaban 20mg daily.
  • No Intervention: No anticoagulation
    Patients allocated to the no anticoagulation arm are not allowed to receive oral anticoagulation, unless the patient develops an indication for its use during follow-up.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
  2. ≥1 episode of clinically significant perioperative AF;
  3. sinus rhythm at the time of randomization; AND

  4. any of the following high-risk criteria:

    1. age ≥55 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score ≥3;
    2. age ≥65 and a CHA2DS2VASc score**** ≥2; OR
    3. age ≥75 years.

Exclusion Criteria:

  1. history of documented 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 (eGFR <30 ml/min);
  6. acute stroke in the past 3 months;
  7. underwent cardiac surgery in the past 3 months;
  8. history of intracranial, intraocular, or spinal bleeding;
  9. hemorrhagic disorder or bleeding diathesis;
  10. expected to be non-compliant with follow-up and/or study medications;
  11. known life expectancy less than 1 year due to concomitant disease;
  12. women who are pregnant, breastfeeding, or of childbearing potential; OR
  13. previously enrolled in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Wells 905-297-3479 ext 41133 aspireaf@phri.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968393
Other Study ID Numbers  ICMJE 2019-ASPIREAF
2019-001336-62 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE
  • Hamilton Health Sciences Corporation
  • Population Health Research Institute
Investigators  ICMJE
Principal Investigator: David Conen, MD, MPH Population Health Research Institute
Study Chair: PJ Devereaux, MD, PhD Population Health Research Institute
PRS Account McMaster University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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