2024-515630-33-00招募中3 期
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 个研究点 分布在 1 个国家目标入组 27,698 人开始时间: 2024年11月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27,698
- 试验地点
- 2
- 主要终点
- The occurrence of clinically relevant leg vein thrombosis.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The occurrence of clinically relevant leg vein thrombosis.
The occurrence of clinically relevant leg vein thrombosis.
次要结局
- Occurrence of clinically relevant and non-relevant leg vein thromboses
- Occurrence of any bleeding (BARC ≥ 1)
研究者
Koordinierender Prüfer
Scientific
Klinikum der Universitaet Muenchen AöR
研究点 (2)
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