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

PHASE4RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 to cause 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 major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
  8. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level;
  9. age ≥75 years.
  10. provide written informed consent

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 not taking effective contraception;
  14. previously enrolled in the trial

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

PREVENTION

phase

Phase

    PHASE4

trial

Study ID

NCT03968393

Intervention or treatment

DRUG: Non-vitamin K oral anticoagulant (NOAC)

Conditions

  • Stroke
  • Atrial Fibrillation

  • Condition: Stroke, Atrial Fibrillation

  • DRUG: Non-vitamin K oral anticoagulant (NOAC)

  • Garran, Australian Capital Territory, Australia and more

  • Sponsor: Population Health Research Institute

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Are you running this trial?

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Research sites nearby

Closest Location:

Canberra Hospital

Select from list below to view details:

  • 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

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Who is running the clinical trial?

PHRI

Population Health Research Institute

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Non-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, 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)
    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.

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Incidence of Non-hemorrhagic stroke or systemic embolismNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolismNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

      Secondary Outcome

      MeasureDescriptionTime Frame
      Incidence of vascular mortalityNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of non-fatal, non-hemorrhagic strokeNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of Myocardial infarctionNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of peripheral arterial thrombosisNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of amputationNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of symptomatic venous thromboembolismNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of all-cause strokeNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Incidence of all-cause mortalityNot SpecifiedFor the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

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