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

Phase 4

Recruiting

• Conditions: Stroke; Atrial Fibrillation
• Interventions: Drug: Non-vitamin K oral anticoagulant (NOAC)

• Registration Number: NCT03968393
• Lead Sponsor: Population Health Research Institute

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.

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 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.

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Study Start: 2019-06-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2270

Inclusion Criteria

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

   1. an overnight hospital admission after surgery;
   2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator

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 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
   2. 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
   3. age ≥75 years.

5. 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; OR
14. previously enrolled in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-vitamin K oral anticoagulant (NOAC)	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.

Primary Outcome Measures

Name	Time	Method
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism	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-hemorrhagic stroke or systemic embolism	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Secondary Outcome Measures

Name	Time	Method
Incidence of non-fatal, non-hemorrhagic stroke	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	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	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	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	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	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	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	For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Trial Locations

Locations (105)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mcgovern Medical School at University of Texas; 🇺🇸 Houston, Texas, United States

Clinica Coronel Suarez; 🇦🇷 Coronel Suárez, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Rosario; 🇦🇷 Rosario, Santa Fe, Argentina

Instituto Cardiovascular de Rosario; 🇦🇷 Rosario, Santa Fe, Argentina

Centro Integral de Arritmias de Tucuman (CIAT); 🇦🇷 San Miguel De Tucumán, Tucuman, Argentina

Hospital Municipal Chivilcoy; 🇦🇷 Chivilcoy, Argentina

Hospital Privado de Rosario; 🇦🇷 Santa Fe, Argentina

Sanatorio Cisma; 🇦🇷 Tucuman, Argentina

Canberra Hospital; 🇦🇺 Garran, Australian Capital Territory, Australia

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