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New treatment option for Deep Vein Thrombosis
Official title Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
ClinicalTrials.gov ID: NCT04694248
What this study is testing
What is Rivaroxaban?
Rivaroxaban is an investigational medicine, given as an once-daily, being studied as a potential treatment for deep vein thrombosis.
Also referred to as Anticoagulant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- IC1. people who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliac venous stenosis (\>50%). The ipsilateral iliac venous stenosis...
- IC2. people who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burden of thrombus, with or without catheter directed thrombolysis...
- IC3. people who accepted iliac venous stent(s) implantation during the perioperative period of PMT or CDT (≤30 days post PMT or CDT) .
You likely can't join if
- 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...
- EC5. Subject has acute arterial embolism on either side or suffers from known moderate or greater stenosis at abdominal aorta, ipsilateral iliac...
- 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...
See the full eligibility criteria
- IC1. people 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)...
- IC2. people who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burden of thrombus, with or without catheter directed thrombolysis (CDT).
- IC3. people who accepted iliac venous stent(s) implantation during the perioperative period of PMT or CDT (≤30 days post PMT or CDT) .
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.