Prevention of thrombotic events in the context of long distance flights

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Klinikum der Universitaet Muenchen AöR

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

completed 12 Nov 2025

Decision date (initial)

2024-11-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DFG - Deutsche Forschungsgemeinschaft (under review) · LMUExcellence Investitionsfund

External identifiers

EU CT number

2024-515630-33-00

EudraCT number

2023-000170-97

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Safety

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.

Secondary objectives 1

1. Secondarily, it is tested whether preventive use of apixaban 2.5 mg can significantly reduce the incidence of clinically relevant and non-relevant leg vein thrombosis in the context of long-haul flights. In addition, the safety profile of apixaban will be investigated in the context of its use as drug thromboprophylaxis in the context of long-haul flights, specifically the occurrence of any bleeding (BARC ≥ 1), which is mapped as a safety endpoint in the study.

Conditions and MedDRA coding

Symptomatic leg vein thrombosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Written, signed and dated electronic informed consent to participate in the clinical trial
2. Legally competent male and female subjects
3. Age ≥ 18 years
4. Long-haul flight to be completed (≥6 h each way)
5. Planned return trip within 4 weeks of departure date
6. 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.
7. 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.
8. Permission to follow up on pregnancies that occur during study participation.

Exclusion criteria 15

1. Taking any antiplatelet therapy and anticoagulation (including all direct oral anticoagulants (DOAKS), vitamin K antagonists, unfractionated and low molecular weight heparins)
2. 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
3. Hypersensitivity to the active ingredient or any of the other ingredients of all study preparations (verum and placebo).
4. No oral medication intake possible at study inclusion, e.g. due to dysphagia of any form, inserted gastrointestinal tube, etc.
5. Known severely impaired renal function
6. Known severe/refractory arterial hypertension (systolic arterial blood pressure >180mmHg)
7. Acute or clinically relevant bleeding within the last 3 months.
8. Any blood donation / blood loss of more than 500 ml within the last 3 months.
9. Liver disease associated with coagulopathy and a clinically relevant risk of bleeding
10. Surgeries and invasive procedures within the last 3 months
11. Known antiphospholipid-syndrome
12. Pregnant and breastfeeding women
13. 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
14. Placement in an institution due to a court or official order
15. 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)).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The occurrence of clinically relevant leg vein thrombosis.

Secondary endpoints 2

1. Occurrence of clinically relevant and non-relevant leg vein thromboses
2. Occurrence of any bleeding (BARC ≥ 1)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Klinikum der Universitaet Muenchen AöR

Sponsor organisation

Klinikum der Universitaet Muenchen AöR

Address

Marchioninistrasse 15, Hadern Hadern

City

Munich

Postcode

81377

Country

Germany

Scientific contact point

Organisation

Klinikum der Universitaet Muenchen AöR

Contact name

Koordinierender Prüfer

Public contact point

Organisation

Klinikum der Universitaet Muenchen AöR

Contact name

Koordinierender Prüfer

Third parties 3

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications