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

Phase 1

Conditions: Symptomatic leg vein thrombosis
MedDRA version: 21.1Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2023-000170-97-DE

Lead Sponsor: MU Universitätsklinikum München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 27698

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

Exclusion Criteria

- Taking any antiplatelet therapy and anticoagulation (including all direct oral anticoagulants (DOAKS), vitamin K antagonists, unfractionated and low molecular weight heparins)
- 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
- 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)).