Antithrombotic Therapy Following Venous Stenting: International Delphi Consensus.
Kristijonas Milinis, Ankur Thapar, Joseph Shalhoub...
https://pubmed.ncbi.nlm.nih.gov/29449145/Actively Recruiting
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-25
172
Participants Needed
1
Research Sites
25 weeks
Total Duration
Researchers are evaluating the safety and effectiveness of combining anticoagulant and antiplatelet therapy to keep the iliac vein open one year after stenting in patients with acute proximal deep vein thrombosis DVT and iliac vein narrowing. This single-arm, open-label study involves 172 adults diagnosed with these conditions who have undergone percutaneous mechanical thrombectomy and iliac vein stenting. The study is conducted across multiple centers in Zhejiang Province, China. Participants will receive rivaroxaban 20 mg once daily for six months along with aspirin 100 mg once daily indefinitely after the stent placement. The study lasts 12 months, with follow-up visits at 3, 6, and 12 months to monitor treatment effects and safety. Evaluations include vein patency, bleeding events, post-thrombotic syndrome severity, and DVT recurrence rates. During the study, participants will have regular assessments to document efficacy and safety outcomes, including clinical evaluations and monitoring for bleeding or other complications. Data collected throughout the 12-month period will be analyzed to understand the combination therapys impact on maintaining vein openness and patient safety after iliac vein stenting.
CONDITIONS
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
H
Hongkun Zhang, M.D.
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First Affiliated Hospital of Zhejiang University
Lead Sponsor
Zhejiang University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months for rivaroxaban; aspirin continues indefinitely
Participants receive anticoagulant therapy with rivaroxaban once daily for 6 months and antiplatelet therapy with aspirin once daily indefinitely following iliac vein stenting.
Visits at 3 months and 6 months post-procedure
Duration - Up to 12 months
Participants are followed to monitor efficacy and safety endpoints after treatment, including patency, bleeding events, post-thrombotic syndrome, and recurrence of deep venous thrombosis.
Visits at 12 months post-procedure
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/30120531/First Affiliated Hospital of Zhejiang University
Lead Sponsor
Zhejiang University
Collaborating Sponsor