Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of combination of anticoagulant and antiplatelet therapy on the patency of iliac vein at 12-month post stenting in patients with acute proximal DVT and ipsilateral iliac vein stenosis who received percutaneous mechanic thrombectomy and iliac vein stenting.

Detailed Description
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This study is a single-arm, prospective, open-label, multicenter study conducted in the Zhejiang Province, China. Randomized controlled trial is not an optimum option at this stage given the lack of high-quality data in terms of this hypothesis. Eligible subjects will include men and women with age of 18 years or older, who have a confirmed diagnosis of acute proximal DVT with ipsilateral iliac vein stenosis. A total of 172 subjects will be enrolled. The inclusion criteria and exclusion criteria are pre-defined. Subjects meeting all inclusion and no exclusion criteria will be eligible for enrollment. All subjects will receive the combination of anticoagulant and antiplatelet therapy after implanted with iliac vein stent. For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.The duration of study participation for each subject is 12 months. Each subject will be followed at 3 months, 6 months and 12 months post-procedure. Efficacy endpoints and safety endpoints will be documented during the follow-up. After completing the follow-up, data will be analyzed.

Official Title
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Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

Conditions
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Deep Vein Thrombosis, Iliac Vein Thrombosis, Iliac Vein Obstruction, Iliac Vein Stenosis, Iliac Vein Compression Syndrome

Intervention / Treatment
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* Drug: Rivaroxaban
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IC1. Subjects who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliac venous stenosis (>50%). The ipsilateral iliac venous stenosis can be caused either by iliac vein compression (i.e. Cockett syndrome) or residue iliac venous thrombus after percutaneous mechanic thrombectomy. IC2. Subjects who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burden of thrombus, with or without catheter directed thrombolysis (CDT). IC3. Subjects who accepted iliac venous stent(s) implantation during the perioperative period of PMT or CDT (≤30 days post PMT or CDT) . Exclusion Criteria: EC1. Subject has chronic DVT or the onset of DVT is longer than 3 weeks, or chronic DVT. EC2. Subject has isolated distal DVT, which does not affect ipsilateral femoral or iliac vein. EC3. Subject has glomerular filtration rate < 60ml/min. EC4. Subject has ipsilateral varicose vein or suffers from ipsilateral venous insufficiency prior to the DVT. The manifestations of venous insufficiency include skin pigmentation, edema, lipodermatosclerosis and venous ulcer. EC5. Subject has acute arterial embolism on either side or suffers from known moderate or greater stenosis at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery. EC6. Subject has known aneurysm(s) or current limiting dissection at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery. EC7. Subject has contraindication to antiplatelet drugs or anticoagulants. EC8. Subject has systemic disease(s) that cannot be treated by current medicine. EC9. Subject has been taking anticoagulants or antiplatelet drugs for other diseases prior to the DVT. EC10. Subject less than 18 years old or rejected to join this study. EC11. Subject has myocardial infarction during the past 6 months. EC12. EC12. Subject who is at high bleeding risk*. * Subject who has at least one of the below conditions will be considered at high bleeding risk: Primary history of intracerebral haemorrhage or ischemic stroke, history of other intracranial pathology, recent gastrointestinal bleeding or anaemia due to possible gastrointestinal blood loss, other gastrointestinal pathology associated with increased bleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age or frailty, or renal failure requiring dialysis or with eGFR <15ml/min/1.73 m2.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anticoagulant plus antiplatelet therapy<br>For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely. | Drug: Rivaroxaban<br>* For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.<br>* Other names: Anticoagulant;Drug: Aspirin<br>* For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.<br>* Other names: Antiplatelet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoints | The primary patency at 12-month follow-up evaluated by DUS | 12-month follow-up | 
| Primary Safety Endpoints | The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up. | 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency | The primary patency at 3-month and 6-month follow-up | 3-month and 6-month follow-up | 
| The rate of bleeding events | The rate of bleeding events based on BARC definitions at 3-month, 6-month and 12-month follow-up | 3-month, 6-month and 12-month follow-up | 
| The rate and severity of post-thrombotic syndrome | The rate and severity of post-thrombotic syndrome (Villalta score) at 3-month, 6-month and 12-month follow-up | 3-month, 6-month and 12-month follow-up | 
| The recurrence rate of deep venous thrombosis | The recurrence rate of deep venous thrombosis evaluated by DUS at 3-month, 6-month and 12-month follow-up | 3-month, 6-month and 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute proximal deep vein thrombosis, iliac vein stenting