RecruitingPHASE4INTERVENTIONAL

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

This international research study, called ASPIRE-AF, is investigating if new blood-thinning medicines, known as NOACs, can help prevent strokes and other serious heart and blood vessel problems. It's for people who have experienced short, temporary episodes of an irregular heartbeat called atrial fibrillation (AF) when their body was under stress, for example, after surgery or during a severe illness. The study aims to compare what happens to people who take these blood thinners versus those who don't, especially focusing on preventing strokes, heart attacks, and other related health issues. Participants will be randomly assigned to one group or the other, and researchers will follow their health over time.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Population Health Research Institute

Enrolment target

2,270

Start

14 Jun 2019

Estimated completion

01 Dec 2028

Stroke Atrial Fibrillation

What is this study about?

Imagine your heart beat as a steady drum. Sometimes, during stressful events like recovering from surgery or a severe illness, this drumbeat can become irregular for a short time – this is called atrial fibrillation (AF). Although these episodes are temporary, doctors are keen to understand if they increase your risk of having a stroke or other serious heart and blood vessel issues later on.

This study, called ASPIRE-AF, is designed to investigate this. It's looking at a type of medicine called a 'Non-vitamin K oral anticoagulant', or NOAC for short, which are blood-thinning drugs. These medicines are already known to prevent strokes in people with ongoing AF. The researchers want to see if they can also help people who only have these temporary, stress-related AF episodes.

The main goal is to compare two groups of people: one group who takes these blood-thinning medicines and another group who does not. By doing this, the researchers hope to find out if taking NOACs can reduce the risk of strokes, heart attacks, and other serious health problems over time for people who have experienced these temporary AF episodes.

Key takeaways

ASPIRE-AF investigates blood thinners for temporary irregular heartbeats (AF).
It aims to prevent strokes and other heart-related problems.
Compares taking a blood thinner (NOAC) versus not taking one.
For people who experienced AF during stress (like surgery or illness).
Participation involves regular check-ups and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to have had at least one episode of an irregular heartbeat (AF) in the last 35 days, which happened after a non-heart-related surgery or during a serious illness that needed hospital care. At the time of joining, your heart rhythm should have returned to normal.

There are also age and other health criteria. For example, if you are 55-64, you would need to have certain other health conditions, like known heart problems or a high-risk score for stroke. If you are 65-74, you would need slightly fewer risk factors, and if you are 75 or older, you might be eligible based on age alone. You must also be able to sign a consent form.

You wouldn't be able to join if you had AF as a long-term condition before your surgery or illness, if you already need blood thinners for another reason, or if you have certain other serious health issues like severe kidney or liver problems, recent stroke, or a high risk of bleeding. Pregnant or breastfeeding women, or those of childbearing potential not using effective contraception, also cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I had a temporary irregular heartbeat (AF) after surgery or severe illness in the last 35 days?
Is my heart rhythm currently normal?
Am I aged 55 or older with certain other health risk factors?
Do I already need to take blood thinners for a long-term condition?
Do I have severe kidney or liver problems, or a high risk of bleeding?
Am I pregnant or breastfeeding, or of childbearing potential and not using effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive the study medicine (a NOAC blood thinner) or not receive it. You wouldn't be able to choose which group you are in. It's an 'open-label' study, meaning both you and your doctor will know whether you are taking the study medicine.

You would have regular check-ups and assessments with the study doctors and nurses over a period of time. This will involve appointments, possibly blood tests, and discussions about your health. The total duration of your participation would depend on the study's plan for how long to follow people up and how your health progresses.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing valuable information that could help others in the future and potentially receiving a medicine that could reduce your risk of stroke. However, there are also potential risks; blood thinners, for example, can increase the risk of bleeding. The study will carefully monitor participants for any side effects or health changes. You will be fully informed about any known risks before you decide to join. Remember, taking part in any research study is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (105)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Mcgovern Medical School at University of Texas
Verified postcode
Houston, United States· Recruiting
Clinica Coronel Suarez
Verified postcode
Coronel Suárez, Argentina· Recruiting
Instituto de Investigaciones Clinicas Rosario
Verified postcode
Rosario, Argentina· Recruiting
Instituto Cardiovascular de Rosario
Verified postcode
Rosario, Argentina· Recruiting
Centro Integral de Arritmias de Tucuman (CIAT)
Verified postcode
San Miguel de Tucumán, Argentina· Recruiting
Hospital Municipal Chivilcoy
Verified postcode
Chivilcoy, Argentina· Recruiting
Sanatorio Cisma
Verified postcode
San Miguel de Tucumán, Argentina· Recruiting
Hospital Privado de Rosario
Verified postcode
Santa Fe, Argentina· Not yet recruiting
Canberra Hospital
Verified postcode
Garran, Australia· Recruiting
Bankstown Hospital
Verified postcode
Bankstown, Australia· Recruiting
Royal Prince Alfred Hospital
Verified postcode
Camperdown, Australia· Recruiting

Common questions

What is atrial fibrillation (AF)?

It's a type of irregular and often fast heartbeat. In this study, we're looking at temporary episodes that happen during stressful times.

What are NOACs?

NOACs are modern blood-thinning medications designed to help prevent blood clots and reduce the risk of stroke.

Will I know if I'm taking the study medicine?

Yes, this is an 'open-label' study, so both you and your doctor will know if you are taking the NOAC medicine or not.

What's the main goal of the study?

The study aims to see if NOACs can prevent strokes and other serious heart problems in people who have had temporary AF episodes during stress.

Can I leave the study once I've joined?

Yes, you have the right to withdraw from the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Cassie McDonald

aspireaf@phri.ca 1-905-594-0560 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.