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Prevention of thrombotic events in the context of long distance flights
EU CTIS ID: 2024-515630-33-00
What this study is testing
The primary objective of the trial is to test whether the preventive use of apixaban 2.5 mg can significantly reduce the incidence of clinically relevant leg vein thrombosis during long-haul flights.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written, signed and dated electronic informed consent to participate in the clinical trial
- Legally competent male and female subjects
- Age ≥ 18 years
- Long-haul flight to be completed (≥6 h each way)
- Planned return trip within 4 weeks of departure date
- Potentially pregnant/pregnant women (as per CTFG V1.1 Sept 2020): Willingness to perform a total of three high-sensitivity urine pregnancy tests (25 mIU/ml for hCG): (1) prior to first single dose of investigational medication (apixaban 2.5 mg or placebo) on outbound flight as part of baseline visit, (2) prior to second single dose of investigational medication (apixaban 2.5 mg or placebo) on return flight, and (3) as part of final visit.
You likely can't join if
- Taking any antiplatelet therapy and anticoagulation (including all direct oral anticoagulants (DOAKS), vitamin K antagonists, unfractionated and low molecular weight heparins)
- Surgeries and invasive procedures within the last 3 months
- Known antiphospholipid-syndrome
- Pregnant and breastfeeding women
- Participation in another interventional study within the last four weeks or five half-lives of the investigational drug in the other interventional study, whichever is longer
- Placement in an institution due to a court or official order
See the full eligibility criteria
- Written, signed and dated electronic informed consent to participate in the clinical trial
- Legally competent male and female subjects
- Age ≥ 18 years
- Long-haul flight to be completed (≥6 h each way)
- Planned return trip within 4 weeks of departure date
- Potentially pregnant/pregnant women (as per CTFG V1.1 Sept 2020): Willingness to perform a total of three high-sensitivity urine pregnancy tests (25 mIU/ml for hCG): (1) prior to first single dose of investigational medication (apixaban 2.5 mg or placebo) on outbound flight as part of baseline visit, (2) prior to second single dose of investigational medication (apixaban 2.5 mg or placebo) on return flight, and (3) as part of final visit.
- Willingness to comply with highly effective contraceptive methods according to CFTG V1.1 Sept 2020 during study participation and until one week after the second single dose of apixaban at return flight.
- Permission to follow up on pregnancies that occur during study participation.
- Taking any antiplatelet therapy and anticoagulation (including all direct oral anticoagulants (DOAKS), vitamin K antagonists, unfractionated and low molecular weight heparins)
- Surgeries and invasive procedures within the last 3 months
- Known antiphospholipid-syndrome
- Pregnant and breastfeeding women
- Participation in another interventional study within the last four weeks or five half-lives of the investigational drug in the other interventional study, whichever is longer
- Placement in an institution due to a court or official order
- Taking undisclosed/unrecommended concomitant medications (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, systemic treatment with potent inhibitors of both CYP3A4 and P-gp, such as azole antifungals (e.g. E.g., ketoconazole, itraconazole, voriconazole, and posaconazole) and HIV protease inhibitors (e.g., ritonavir)).
- Lesions or clinical situations if considered a significant risk factor for major bleeding. This includes, but is not limited to, acute or recent gastrointestinal ulceration; malignant neoplasms with high bleeding risk; recent brain or spinal cord injury; recent brain, spinal cord, or eye surgery; recent intracranial hemorrhage; known or suspected esophageal varices; arteriovenous malformations; vascular aneurysms; or major intraspinal or intracerebral vascular abnormalities
- Hypersensitivity to the active ingredient or any of the other ingredients of all study preparations (verum and placebo).
- No oral medication intake possible at study inclusion, e.g. due to dysphagia of any form, inserted gastrointestinal tube, etc.
- Known severely impaired renal function
- Known severe/refractory arterial hypertension (systolic arterial blood pressure >180mmHg)
- Acute or clinically relevant bleeding within the last 3 months.
- Any blood donation / blood loss of more than 500 ml within the last 3 months.
- Liver disease associated with coagulopathy and a clinically relevant risk of bleeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.