Prevalence of clinical venous thromboembolism in the USA: current trends and future projections.
S B Deitelzweig, B H Johnson, J Lin...
https://pubmed.ncbi.nlm.nih.gov/21264912Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04694248
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-25
172
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 therapy's impact on maintaining vein openness and patient safety after iliac vein stenting.
CONDITIONS
Brief Title
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with deep venous thrombosis (DVT) and ipsilateral iliac vein stenosis greater than 50%
- Have undergone percutaneous mechanical thrombectomy, with or without catheter-directed thrombolysis
- Received iliac vein stent implantation within 30 days of thrombectomy or thrombolysis
- Adults aged 18 years or older
You will not qualify if you...
- Chronic DVT or DVT onset longer than 3 weeks
- Isolated distal DVT not affecting the ipsilateral femoral or iliac vein
- Glomerular filtration rate less than 60 ml/min
- Presence of ipsilateral varicose veins or venous insufficiency before DVT
- Acute arterial embolism or significant stenosis in abdominal aorta, ipsilateral iliac artery, or lower extremity artery
- Known aneurysms or limiting dissections in relevant arteries
- Contraindications to antiplatelet or anticoagulant drugs
- Untreatable systemic diseases
- Prior use of anticoagulants or antiplatelet drugs before DVT
- Under 18 years old or unwilling to participate
- Myocardial infarction within the past 6 months
- High bleeding risk due to conditions like intracerebral hemorrhage, recent gastrointestinal bleeding, liver failure, coagulopathy, extreme frailty, or severe renal failure requiring dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
The First Affliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Loading map...
Research Team
H
Hongkun Zhang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial.
Ylva Haig, Tone Enden, Ole Grøtta...
https://pubmed.ncbi.nlm.nih.gov/26853645Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry.
Mark J Garcia, Robert Lookstein, Rahul Malhotra...
https://pubmed.ncbi.nlm.nih.gov/25824314Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis.
Anthony J Comerota, Clive Kearon, Chu-Shu Gu...
https://pubmed.ncbi.nlm.nih.gov/30586751Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis.
Mahmood K Razavi, Michael R Jaff, Larry E Miller
https://pubmed.ncbi.nlm.nih.gov/26438686Stent patency in patients with advanced chronic venous disease and nonthrombotic iliac vein lesions.
Syed Ali Rizvi, Enrico Ascher, Anil Hingorani...
https://pubmed.ncbi.nlm.nih.gov/29909853Antithrombotic Therapy Following Venous Stenting: International Delphi Consensus.
Kristijonas Milinis, Ankur Thapar, Joseph Shalhoub...
https://pubmed.ncbi.nlm.nih.gov/29449145Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease.
Paul A Gurbel, Keith A A Fox, Udaya S Tantry...
https://pubmed.ncbi.nlm.nih.gov/31034291Combination of factor Xa inhibition and antiplatelet therapy after stenting in patients with iliofemoral post-thrombotic venous obstruction.
Nicolas Langwieser, Isabell Bernlochner, Isabel Wustrow...
https://pubmed.ncbi.nlm.nih.gov/26183668Antiplatelet Therapy is Associated with Stent Patency After Iliocaval Venous Stenting.
Masayuki Endo, Younes Jahangiri, Masahiro Horikawa...
https://pubmed.ncbi.nlm.nih.gov/30120531