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

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.

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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.

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Eligibility criteria

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

Inclusion criteria

noncardiac surgery in the past 35 days with at least one of the following: an overnight hospital admission after surgery; day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator

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

sinus rhythm at the time of randomization

any of the following high-risk criteria: age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level; 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 age ≥75 years

provide written informed consent

Exclusion criteria

history of documented chronic AF prior to noncardiac surgery

need for long-term systemic anticoagulation

ongoing need for long-term dual antiplatelet treatment

contraindication to oral anticoagulation

severe renal insufficiency (CrCl <20 ml/min)

severe liver cirrhosis (i.e., Child-Pugh Class C)

acute stroke in the past 14 days

underwent cardiac surgery in the past 35 days

history of nontraumatic intracranial, intraocular, or spinal bleeding

hemorrhagic disorder or bleeding diathesis

expected to be non-compliant with follow-up and/or study medications

known life expectancy less than 1 year due to concomitant disease

women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception

previously enrolled in the trial

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Eligibility

Age eligible for study : 55 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2019-06-14

Primary completion: 2026-12-01

Study completion finish: 2028-12-01

Study type

PREVENTION

Phase

PHASE4

Trial 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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Find a site

Closest Location:

Canberra Hospital

Research sites nearby

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

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/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 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) Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: 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.	Not specified

Participant Group/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 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)

Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: 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.

Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of Non-hemorrhagic stroke or systemic embolism	Not Specified	For 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 thromboembolism	Not Specified	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Incidence of vascular mortality	Not Specified	For 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 stroke	Not Specified	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Incidence of Myocardial infarction	Not Specified	For 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 thrombosis	Not Specified	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)
Incidence of amputation	Not Specified	For 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 thromboembolism	Not Specified	For 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 stroke	Not Specified	For 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 mortality	Not Specified	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Frequently Asked Questions

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References

Clinical Trials Gov: Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery