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Study on Apixaban for Preventing Blood Clots in Leg Veins During Long-Distance Flights for Travelers at Risk

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of blood clots, specifically leg vein thrombosis, which can occur during long-distance flights. The trial will use a medication called Apixaban, which is taken in the form of a 2.5 mg film-coated tablet. The purpose of the study is to determine if taking a single dose of Apixaban can significantly reduce the risk of developing leg vein thrombosis during long-haul flights.

Participants in the study will be given either the Apixaban tablet or a placebo, which looks like the real medication but does not contain the active ingredient. The study will involve taking the medication before the outbound flight and again before the return flight. The trial aims to observe the occurrence of any clinically relevant leg vein thrombosis during these flights.

The study will also monitor for any bleeding events, as this is a potential side effect of taking Apixaban. The trial is expected to run until 2028, with recruitment starting in 2026. This research is important for understanding how to prevent blood clots in people who travel long distances by air, which can be a risk factor for developing such conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will attend an initial visit where you will be asked to provide written, signed, and dated electronic informed consent to participate in the clinical trial.

    During this visit, eligibility will be confirmed, ensuring you are legally competent, aged 18 or older, and planning a long-haul flight of at least 6 hours each way with a return trip within 4 weeks.

  2. Step 2

    Baseline visit and first dose

    Before your outbound flight, you will attend a baseline visit. If you are a potentially pregnant or pregnant woman, you will perform a high-sensitivity urine pregnancy test.

    You will receive a single dose of the investigational medication, apixaban 2.5 mg, or a placebo, to be taken orally as a film-coated tablet before your flight.

  3. Step 3

    Return flight and second dose

    Before your return flight, you will take a second single dose of the investigational medication, apixaban 2.5 mg, or a placebo.

    If applicable, a second high-sensitivity urine pregnancy test will be conducted prior to taking the medication.

  4. Step 4

    Final visit

    After completing your return flight, you will attend a final visit. If you are a potentially pregnant or pregnant woman, a third high-sensitivity urine pregnancy test will be performed.

    The study will monitor for the occurrence of clinically relevant leg vein thrombosis and any bleeding events.

Who can join the trial?

10 criteria

  • Provide a written, signed, and dated electronic consent to participate in the clinical trial.
  • Be a legally competent male or female.
  • Be at least 18 years old.
  • Plan to take a long-haul flight (lasting at least 6 hours each way).
  • Have a planned return trip within 4 weeks of the departure date.
  • If you are a woman who is potentially pregnant or pregnant, you must be willing to take three high-sensitivity urine pregnancy tests (these tests check for a hormone called hCG to confirm pregnancy):
    • Before taking the first dose of the study medication on the outbound flight.
    • Before taking the second dose of the study medication on the return flight.
    • At the final visit of the study.
    • Be willing to use highly effective contraceptive methods during the study and until one week after the second dose of the study medication on the return flight.
    • Allow follow-up on any pregnancies that occur during the study.

Who cannot join the trial?

3 criteria

  • Patients with a history of symptomatic leg vein thrombosis cannot participate. This means if you have had noticeable symptoms from blood clots in your leg veins, you are not eligible.
  • Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
  • Participants who are part of a vulnerable population are not eligible. This refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Apixaban is a medication used to prevent blood clots. In this clinical trial, it is being tested to see if it can help reduce the risk of developing blood clots in the legs during long flights. Blood clots can be dangerous because they can block blood flow in the veins, leading to pain and swelling. In some cases, they can travel to other parts of the body, like the lungs, which can be life-threatening. By taking apixaban, the trial aims to see if it can lower the chances of these clots forming, making long-distance travel safer for people at risk of thrombosis.

What is already known about the treatment

Apixaban – Apixaban is a medication taken orally, usually in the form of a tablet, and is used to prevent blood clots. It is currently being studied for its effectiveness in reducing the risk of leg vein thrombosis, especially during long-distance flights. The main therapeutic use of apixaban is to prevent and treat conditions where blood clots form in the veins, such as deep vein thrombosis. At the molecular level, apixaban works by inhibiting a specific protein in the blood called Factor Xa, which plays a crucial role in the blood clotting process. It belongs to a class of drugs known as anticoagulants, which help to keep blood flowing smoothly by preventing clots from forming.

Investigated diseases

Leg Vein Thrombosis – Leg vein thrombosis, also known as deep vein thrombosis (DVT), is a condition where a blood clot forms in a deep vein, typically in the legs. This condition can cause swelling, pain, and redness in the affected area. The clot can restrict blood flow, leading to increased pressure in the veins. Over time, the clot may cause damage to the vein and surrounding tissues. If the clot dislodges, it can travel to the lungs, causing a serious condition known as pulmonary embolism. The progression of leg vein thrombosis can vary, with some cases resolving on their own while others may lead to complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515630-33-00Protocol code2023-01-1200-01Estimated enrolment27 698 patientsSponsorKlinikum Der Universitat Munchen AöR

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