2024-515630-33-00
Not yet recruiting
Phase 3
A single dose of apixaban for the prevention of thrombotic events in the context of long-distance flights (DANCE FLIGHT)
Klinikum der Universitaet Muenchen AöR2 sites in 1 country27,698 target enrollmentStarted: November 11, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Klinikum der Universitaet Muenchen AöR
- Enrollment
- 27,698
- Locations
- 2
- Primary Endpoint
- The occurrence of clinically relevant leg vein thrombosis.
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion 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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The occurrence of clinically relevant leg vein thrombosis.
The occurrence of clinically relevant leg vein thrombosis.
Secondary Outcomes
- Occurrence of clinically relevant and non-relevant leg vein thromboses
- Occurrence of any bleeding (BARC ≥ 1)
Investigators
Koordinierender Prüfer
Scientific
Klinikum der Universitaet Muenchen AöR
Study Sites (2)
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