Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

September 22, 2025 updated by: Hongkun Zhang, MD, First Affiliated Hospital of Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affliated Hospital, Zhejiang University, School of Medicine
        • Contact:
          • Hongkun Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anticoagulant plus antiplatelet therapy
For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
Drug: Rivaroxaban
For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.
Other Names:
  • Anticoagulant
Drug: Aspirin
For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
Other Names:
  • Antiplatelet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoints
Time Frame: 12-month follow-up
The primary patency at 12-month follow-up evaluated by DUS
12-month follow-up
Primary Safety Endpoints
Time Frame: 12-month follow-up
The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up.
12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency
Time Frame: 3-month and 6-month follow-up
The primary patency at 3-month and 6-month follow-up
3-month and 6-month follow-up
The rate of bleeding events
Time Frame: 3-month, 6-month and 12-month follow-up
The rate of bleeding events based on BARC definitions at 3-month, 6-month and 12-month follow-up
3-month, 6-month and 12-month follow-up
The rate and severity of post-thrombotic syndrome
Time Frame: 3-month, 6-month and 12-month follow-up
The rate and severity of post-thrombotic syndrome (Villalta score) at 3-month, 6-month and 12-month follow-up
3-month, 6-month and 12-month follow-up
The recurrence rate of deep venous thrombosis
Time Frame: 3-month, 6-month and 12-month follow-up
The recurrence rate of deep venous thrombosis evaluated by DUS at 3-month, 6-month and 12-month follow-up
3-month, 6-month and 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

Boston Scientific Corporation
Zhejiang University
The Central Hospital of Lishui City
Taizhou First People's Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Ningbo No.2 Hospital
Taizhou Enze Medical Center Group

Investigators

  • Principal Investigator: Hongkun Zhang, M.D., First Affiliated Hospital of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 1, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20200040C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Vein Thrombosis

Clinical Trials on Rivaroxaban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe