Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A single dose of apixaban for the prevention of thrombotic events in the context of long-distance flights (DANCE FLIGHT)

This study, called DANCE FLIGHT, is investigating if one dose of a blood-thinning medicine, apixaban (also known as Eliquis), can prevent blood clots in the legs for people going on long plane journeys. Blood clots in the legs, called deep vein thrombosis (DVT), can sometimes happen during long flights due to sitting still for extended periods. Researchers want to confirm if this medication can significantly reduce the chance of these clots forming. They will also be looking at any side effects, like bleeding, to make sure it's a safe option. The study is open to adults aged 18 and over, both men and women, who might be at risk of these clots.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Klinikum der Universitaet Muenchen AöR

Enrolment target

27,698

Start

11 Nov 2024

Symptomatic leg vein thrombosis

What is this study about?

Imagine you're planning a long flight, perhaps to visit family or go on holiday. Sitting still for many hours can sometimes lead to a problem called a deep vein thrombosis (DVT), which is a blood clot that forms in the deep veins of your leg. While not everyone gets them, they can be serious.

This study, called DANCE FLIGHT, is looking into whether a single dose of a medicine named apixaban, also known by the brand name Eliquis, can help prevent these leg blood clots when you travel by plane for a long time. Eliquis is a medicine that helps to thin the blood, making it less likely to clot.

The main goal of the study is to see if taking this medicine just once before a long flight reduces the number of participants who develop these leg clots. The researchers will also carefully monitor for any bleeding, as thinning the blood can sometimes increase the risk of bleeding. The results will help decide if this could be a safe and effective way to protect people from clots during long-distance air travel.

Key takeaways

The study tests a single dose of apixaban (Eliquis) to prevent leg blood clots during long flights.
It's open to adults aged 18 or older, both men and women.
The main goal is to see if the medicine reduces clot risk and to monitor for bleeding side effects.
Participation involves taking a dose before your flight and follow-up checks.
You have the right to withdraw from the study at any stage.
This is a Phase III study, meaning it's in an advanced stage of testing.

Who may be eligible?

This study is looking for volunteers who are adults, aged 18 years or older. There is no upper age limit, meaning older adults are also welcome to participate if they meet other health criteria.

Both men and women can take part in this research. The study needs a diverse group of people to understand how the medicine works across different individuals.

To join, you would need to meet certain health requirements which the study doctors will explain fully. These typically ensure that taking the study medicine would be safe for you and that the results of the study are clear and reliable. For instance, they would check if you have any existing medical conditions or are taking other medicines that might interfere with apixaban.

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.

Are you 18 years old or older?
Plan to take a long-distance flight soon?
Are you comfortable with taking a study medicine or dummy pill?
Do you understand that there will be follow-up health checks?
Are you able to attend all required appointments?
Have you discussed your overall health with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine (apixaban) or a dummy pill (placebo) – you wouldn't know which one you're getting, nor would the doctors. This is standard in research to get unbiased results. You would take this single dose before your long-distance flight. There will be initial health checks and discussions with the study team before you travel.

After your flight, there will be follow-up appointments, which may involve physical examinations and perhaps some scans or blood tests, to see if you developed any leg clots and to check for any side effects. The total duration of your involvement, from your initial checks to the final follow-up after your flight, will be explained in detail by the study team. They will ensure you understand all appointments and assessments involved.

Potential risks and benefits

Participating in this study might offer the potential benefit of reducing your risk of blood clots during long flights, particularly if you receive the active medicine. However, like all medicines, apixaban carries potential risks, primarily an increased chance of bleeding. This bleeding could range from minor (like easy bruising) to more serious, which is why close monitoring is part of the study. You have the complete right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is apixaban (Eliquis) used for normally?

Apixaban (Eliquis) is a medicine usually prescribed to prevent and treat blood clots in various situations, such as after certain surgeries or for people with specific heart conditions.

What is a 'long-distance flight' in this study?

The study will define what they consider a 'long-distance flight,' but generally, it refers to flights where you are seated for an extended period, typically several hours or more, increasing the risk of clots.

Will I know if I'm getting the real medicine or a dummy pill?

No, you won't know, and neither will the study doctors. This is called 'blinding' and is a common practice in research to ensure the study results are fair and accurate.

Are there any costs involved for me to participate?

No, participating in a clinical trial typically does not cost you anything. All study-related medication, tests, and appointments are usually covered by the researchers.

What if I decide the study isn't right for me after joining?

You are free to leave the study at any time, for any reason, without having to explain why. This will not affect your relationship with your doctors or your future medical care.