At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Non-vitamin K oral anticoagulant (NOAC) (drug)
- How long the study runs
- Study runs about 114 months (dates as stated)
- About the drug or intervention
- Non-vitamin K oral anticoagulant (NOAC) — drug: 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).
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether blood-thinning medicine (anticoagulation) can help prevent stroke in people who had a short episode of a heart rhythm problem called atrial fibrillation (AF) during a time of physical stress, such as surgery or a serious illness. The episodes happened only temporarily and the heart had returned to its normal rhythm. The sponsor is the Population Health Research Institute.
Who can take part
- Had at least one episode of atrial fibrillation that came on with stress, within the past 35 days
- The episode happened during or after non-cardiac surgery with an overnight hospital stay, or after day surgery or a hospital admission for an acute illness that was stressful enough to the body to trigger it (as judged by the local researcher)
- The heart is back in its normal rhythm when joining the study
- Have a higher risk of stroke, based on age (55 and over) combined with things like heart or blood vessel disease, recent major vascular surgery, a certain risk score, or raised troponin levels after surgery
- Able to give written informed consent
Who may not be able to
- Admitted to hospital mainly for a heart problem
- Known long-standing atrial fibrillation before the surgery
- Already need long-term blood thinners
- Need long-term treatment with two antiplatelet medicines
- Cannot take oral blood thinners for health reasons
- Severe kidney problems
- Severe liver scarring (severe cirrhosis)
- A stroke in the past 14 days
- Heart surgery in the past 35 days
- Past bleeding in the brain, eye, or spine that was not caused by injury
- A bleeding disorder
- Unlikely to attend follow-up visits or take study medicines
- Expected to live less than 1 year due to another illness
- Pregnant, breastfeeding, or able to become pregnant without using effective contraception
- Already took part in this trial before
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 55 Years and over
- Who
- All
- Number of participants
- 2,270
- Started
- 2019-06-14
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for stroke
- • Phase4 - 2,270 participants
- • Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors
Who can take part?
- • Ages 55 Years and over
- • Diagnosed with stroke
Where?
- • Liverpool - Liverpool Heart and Chest Hospital
- • Westcliff-on-Sea - Southend Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
More detail
ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient atrial fibrillation and additional stroke factors occurring transiently with stress. 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 55 Years and over
- Who can join: All genders
What the study is looking for
- ✓have ≥1 episode of clinically important AFOTS during any of the following conditions:
- ✓noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
- ✓noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the...
- ✓acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological...
- ✓sinus rhythm at the time of randomization;
Who cannot take part
- ✗any heart diagnosis as the primary reason for hospital admission;
- ✗history of documented chronic AF prior to noncardiac surgery;
- ✗need for long-term systemic anticoagulation;
- ✗ongoing need for long-term dual antiplatelet treatment;
- ✗safety concern to oral anticoagulation;
See the full criteria
Where Is This Study? (2 UK sites)
Liverpool Heart and Chest Hospital
Liverpool L14 3PE, United Kingdom
Southend Hospital
Westcliff-on-Sea SS0 0RY, United Kingdom
How to Get in Touch
Cassie McDonald
Sponsor contactCONTACT