Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Jan 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how well a combination of two types of blood-thinning medications—anticoagulants and antiplatelets—works for patients who have had a procedure to open up blocked iliac veins. These blockages can be caused by conditions like deep vein thrombosis (DVT) and can lead to serious complications if not treated. The goal is to see if this combination therapy helps keep the iliac vein open for at least 12 months after the stenting procedure, which is when a small tube is placed in the vein to keep it open.

To be eligible for this study, participants must be between 65 and 74 years old and diagnosed with DVT along with significant blockage in their iliac vein. They should have undergone a procedure to remove the clot (called percutaneous mechanical thrombectomy) and had a stent placed within a month after that. However, people with certain conditions, like long-term DVT, specific types of vascular issues, or those at high risk for bleeding, cannot participate. If you join this trial, you can expect close monitoring to ensure your safety and to check how well the treatment is working over the next year.

Gender

ALL

Eligibility criteria

• 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.