Aspirin® plus rivaroxaban versus rivaroxaban alone for the prevention of venous stent thrombosis in patients with post-thrombotic syndrome (long-term condition associated with redness, swelling, leg pain, and ulcers as a results of deep vein thrombosis)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 316

Inclusion Criteria

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:
? inferior vena cava
? iliac vein or
? common femoral vein
6. Patients either on active treatment with rivaroxaban or patients planned for treatment with rivaroxaban after intervention
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

Exclusion Criteria

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 and / or switch from vitamin K antagonist (VKA) to 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) 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)
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show if additional therapy with Aspirin® is more efficient than basic medication alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy.;Secondary Objective: To demonstrate tolerability of additional therapy with Aspirin® to basic medictaion in long-term treatment. ;Primary end point(s): The primary patency rate after 6 months (=Visit 3) is considered to be the primary endpoint. <br>The primary patency rate is defined as the percentage of patients with primary treatment success, i.e. without the occurrence of either i) occlusion of at least a part of the stent segment or ii.) a re-intervention to maintain patency of the treated segment.<br>;Timepoint(s) of evaluation of this end point: After 6 months (Visit 3)

Secondary Outcome Measures

Name	Time	Method

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