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

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ClinicalTrials.gov Identifier: NCT03968393
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : October 25, 2022
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Population Health Research Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Atrial Fibrillation Drug: Non-vitamin K oral anticoagulant (NOAC) Phase 4

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 perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. The primary objective is to assess the effects of NOACs 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 24 months after randomization.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 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 Trial
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : December 2026

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for 24 months, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.
 Drug: Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for 24 months: 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.
No Intervention: No anticoagulation
Participants randomized to the control arm will not be prescribed an oral anticoagulant unless they develop a clear indication for one during follow-up (e.g., recurrent nonoperative AF). They can be newly prescribed or continue taking low dose aspirin or another single antiplatelet agent as per the protocol. This will be decided by the participant's physician.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Non-hemorrhagic stroke or systemic embolism [ Time Frame: Up to 24 months, until final follow-up ]
  2. Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism [ Time Frame: Up to 24 months, until final follow-up ]

Secondary Outcome Measures :
  1. Incidence of vascular mortality [ Time Frame: Up to 24 months, until final follow-up ]
  2. Incidence of non-fatal, non-hemorrhagic stroke [ Time Frame: Up to 24 months, until final follow-up ]
  3. Incidence of Myocardial infarction [ Time Frame: Up to 24 months, until final follow-up ]
  4. Incidence of peripheral arterial thrombosis [ Time Frame: Up to 24 months, until final follow-up ]
  5. Incidence of amputation [ Time Frame: Up to 24 months, until final follow-up ]
  6. Incidence of symptomatic venous thromboembolism [ Time Frame: Up to 24 months, until final follow-up ]
  7. Incidence of all-cause stroke [ Time Frame: Up to 24 months, until final follow-up ]
  8. Incidence of all-cause mortality [ Time Frame: Up to 24 months, until final follow-up ]

Other Outcome Measures:
  1. 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

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

  3. Safety objective: incidence of hemorrhagic stroke [ Time Frame: Up to 24 months, until final follow-up ]
  4. Tertiary objective: hospitalization for vascular causes [ Time Frame: Up to 24 months, until final follow-up ]
  5. Tertiary objective: hospitalization for all causes [ 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 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 55-74 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score ≥3;OR
    2. 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 nontraumatic 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 who are not taking effective contraception; OR
  13. previously enrolled in the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968393


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

Locations
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Sponsors and Collaborators
Population Health Research Institute
Hamilton Health Sciences Corporation
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
More Information
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03968393    
Other Study ID Numbers: 2019-ASPIREAF
2019-001336-62 ( EudraCT Number )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
Transient Atrial Fibrillation
Perioperative Atrial Fibrillation
Non-vitamin K Oral Anticoagulation
Noncardiac Surgery
PROBE Design
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Anticoagulants