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Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

Primary Purpose

Deep Vein Thrombosis, Iliac Vein Thrombosis, Iliac Vein Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rivaroxaban
Aspirin
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring acute proximal deep vein thrombosis, iliac vein stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affliated Hospital, Zhejiang University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anticoagulant plus antiplatelet therapy

Arm Description

For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 1, 2021
Last Updated
February 20, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Zhejiang University, Ningbo No.2 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Taizhou Enze Hospital, Taizhou First People's Hospital, Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04694248
Brief Title
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Official Title
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Zhejiang University, Ningbo No.2 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Taizhou Enze Hospital, Taizhou First People's Hospital, Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Iliac Vein Thrombosis, Iliac Vein Obstruction, Iliac Vein Stenosis, Iliac Vein Compression Syndrome
Keywords
acute proximal deep vein thrombosis, iliac vein stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anticoagulant plus antiplatelet therapy
Arm Type
Experimental
Arm Description
For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Anticoagulant
Intervention Description
For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Antiplatelet
Intervention Description
For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoints
Description
The primary patency at 12-month follow-up evaluated by DUS
Time Frame
12-month follow-up
Title
Primary Safety Endpoints
Description
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 Outcome Measure Information:
Title
Patency
Description
The primary patency at 3-month and 6-month follow-up
Time Frame
3-month and 6-month follow-up
Title
The rate of bleeding events
Description
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
Title
The rate and severity of post-thrombotic syndrome
Description
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
Title
The recurrence rate of deep venous thrombosis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongkun Zhang, M.D.
Phone
0571-87236745
Email
1198050@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongkun Zhang, M.D.
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affliated Hospital, Zhejiang University, School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongkun Zhang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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21264912
Citation
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Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

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