Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Rivaroxaban

    Drug

    For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.

  • Aspirin

    Drug

    For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.

Treatment groups

172 Participants
are divided into 1 treatment group
Group A: Anticoagulant plus antiplatelet therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Primary Effectiveness Endpoints

The primary patency at 12-month follow-up evaluated by DUS

Time frame
12-month follow-up
2

Primary Safety Endpoints

The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up.

Time frame
12-month follow-up

Secondary outcomes

1

Patency

The primary patency at 3-month and 6-month follow-up

Time frame
3-month and 6-month follow-up
2

The rate of bleeding events

The rate of bleeding events based on BARC definitions at 3-month, 6-month and 12-month follow-up

Time frame
3-month, 6-month and 12-month follow-up
3

The rate and severity of post-thrombotic syndrome

The rate and severity of post-thrombotic syndrome (Villalta score) at 3-month, 6-month and 12-month follow-up

Time frame
3-month, 6-month and 12-month follow-up
4

The recurrence rate of deep venous thrombosis

The recurrence rate of deep venous thrombosis evaluated by DUS at 3-month, 6-month and 12-month follow-up

Time frame
3-month, 6-month and 12-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

Zhejiang University

Collaborator

Ningbo No.2 Hospital

Collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Collaborator

The Central Hospital of Lishui City

Collaborator

Taizhou Enze Medical Center Group

Collaborator

Taizhou First People's Hospital

Collaborator

Boston Scientific Corporation

Collaborator