Symptomatic leg vein thrombosis MedDRA version: 21.1 Level: PT Classification code 10051055 Term: Deep vein thrombosis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Apixaban
CAS Number: 503612-47-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of
Sponsors
LMU Universitätsklinikum München
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 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.;Primary end point(s): The occurrence of clinically relevant leg vein thrombosis.;Timepoint(s) of evaluation of this end point: Within two weeks after arrival of the return flight. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Occurrence of clinically relevant and non-relevant leg vein thromboses - Occurrence of any bleeding (BARC = 1);Timepoint(s) of evaluation of this end point: Within two weeks after arrival of the return flight. | — |
Countries
Germany
Contacts
Public ContactClinical Trial Management
LMU Universitätsklinikum München
Outcome results
None listed