NCT04694248

Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Deep Vein Thrombosis
• Iliac Vein Thrombosis
• Iliac Vein Obstruction
• Iliac Vein Stenosis
• Iliac Vein Compression Syndrome

Interventions

Type	Name	Description
DRUG	Rivaroxaban	For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.
DRUG	Aspirin	For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.

Timeline

• Start date: 2021-11-03
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2021-01-05
• Last updated: 2025-09-25

Locations

1 site across 1 country: China