EUCTR2019-001723-12-AT进行中（未招募）1 期
Aspirin® plus rivaroxaban versus rivaroxaban alone for the prevention of venous stent thrombosis in patients with post-thrombotic syndrome - ARIVA venous
niversitätsspital Zürich, Klinik für Angiologie0 个研究点目标入组 316 人开始时间: 2020年1月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 316
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent form and - in EU countries only - data protection declaration obtained prior to any trial-specific procedures
- •2. Patient aged =18 and <75 years
- •3. Confirmed diagnosis of post-thrombotic syndrome defined as Villalta score > 4 points prior to enrolment and venous stent intervention
- •4. Confirmed stenosis of inferior vena cava, iliac vein, or common femoral vein by duplex ultrasound or cross-sectional imaging (CT venography or MR venography) prior to enrolment and venous stent intervention
- •5. Successfully conducted venous stent intervention involving either:
- •o inferior vena cava
- •o iliac vein or
- •o common femoral vein
- •6. Patients on active treatment with rivaroxaban
- •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 266
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Previous venous intervention in target vessels
- •2. Any contraindication for antithrombotic therapy (e.g. active gastric ulcer, duodenal ulcer, bleeding disorder with increased tendency of bleedings)
- •3. Patients with any history of gastrointestinal or urogenital bleeding except menstrual bleeding
- •4. Patients with a recent (3 months) clinically significant bleeding and / or active or recent (3 months) ulcerative or inflammatory gastrointestinal disease (including esophagitis and gastro-esophageal reflux disease)
- •5. Patients with a significant risk for severe bleeding, e.g. recent (3 months) brain or spinal cord injuries, recent (3 months) brain, spinal cord or eye surgery, recent (3 months) intracranial bleeding, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm, larger intraspinal or intracerebral vascular anomalies
- •6. Intake (concomitantly and / or within 7 days prior to Visit 1) of anticoagulants (heparins including derivatives [except of use of unfractionated heparin on the day intervention and the use of enoxaparin instead of rivaroxaban within 2 weeks after Visit 1], oral anticoagulants [except of use of rivaroxaban], thrombolytics, antiplatelet treatment and acetylsalicylic acid [except of use of IMP])
- •7. Acute thrombosis (venous thromboembolism events < 3 months prior to Visit 1) or previous thrombosis with diagnosed antiphospholipid syndrome
- •8. Pre-existing coagulopathy and / or hemorrhagic diathesis
- •9. Uncontrolled severe arterial hypertension
- •10. Vascular retinopathy
- •11. Bronchiectasia, history of pulmonic bleedings and / or asthma attack caused by use of salicylates or drugs with similar effects, especially NSAIDs
- •12. Acute bacterial endocarditis
- •13. Prior stroke or transient ischemic attack (< 12 months prior to Visit 1)
- •14. Hereditary galactose intolerance, total lactase deficiency, glucose-galactose malabsorption and / or severe glucose-6-phosphate-dehydrogenase deficiency
- •15. Pregnancy, breast feeding, or planned pregnancy within the trial period or women of childbearing potential not using an adequate method of contraception
- •16. Severe heart, liver (including those associated with a coagulopathy) or kidney (e.g. eGFR < 50 mL/min)or kidney (e.g. eGFR < 50 mL/min) disease
- •17. Severe somatopathic, neurological and / or psychiatric disease(s)
- •18. Malignant growth (concurrent or previous cancer with a relapse-free and treatment-free interval of less than 5 years before Visit 1)
- •19. Known hypersensitivity to acetylsalicylic acid (Aspirin® cardio or Aspirin® protect and / or its excipients), to other antiphlogistic drugs, to analgesics, to anti-fever drugs or to rivaroxaban (Xarelto® and / or its excipients)
- •20. Concomitant intake of methotrexate > 15 mg per week, strong inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (azole antimycotics, e.g. ketoconazole; HIV protease inhibitors), strong inductors of CYP3A4 (rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s wort), dronedarone, digoxin, valproic acid, selective serotonin reuptake inhibitors (SSRI), serotonin noradrenalin reuptake inhibitors (SNRI), systemic glucocorticoids and / or non-steroidal anti-inflammatory drugs (NSAIDs; long-term use)
- •21. Parallel participation in another clinical trial, participation in a clinical trial within less than 6 weeks prior to the Screening visit or previous participation in this clinical trial
- •22. Known to be, or suspected of being unable to comply with the trial pro
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