Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

NCT04694248 | Recruiting

• 1 other identifier: IIT20200040C
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoints

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

  12-month follow-up

• Primary Safety Endpoints

  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 Outcomes (4)

• Patency

  3-month and 6-month follow-up

• The rate of bleeding events

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

• The rate and severity of post-thrombotic syndrome

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

• The recurrence rate of deep venous thrombosis

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

Study Arms (1)

Anticoagulant plus antiplatelet therapy

EXPERIMENTAL

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; Drug: Aspirin

Interventions

Rivaroxaban DRUG

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

Also known as: Anticoagulant

Anticoagulant plus antiplatelet therapy

Aspirin DRUG

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

Also known as: Antiplatelet

Anticoagulant plus antiplatelet therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• 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

Study Sites (1)

The First Affliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (10)

• Deitelzweig SB, Johnson BH, Lin J, Schulman KL. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol. 2011 Feb;86(2):217-20. doi: 10.1002/ajh.21917.

  PMID: 21264912 BACKGROUND

• Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6.

  PMID: 26853645 BACKGROUND

• Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular 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. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.

  PMID: 25824314 BACKGROUND

• Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.

  PMID: 30586751 BACKGROUND

• Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015 Oct;8(10):e002772. doi: 10.1161/CIRCINTERVENTIONS.115.002772.

  PMID: 26438686 BACKGROUND

• Rizvi SA, Ascher E, Hingorani A, Marks N. Stent patency in patients with advanced chronic venous disease and nonthrombotic iliac vein lesions. J Vasc Surg Venous Lymphat Disord. 2018 Jul;6(4):457-463. doi: 10.1016/j.jvsv.2018.02.004.

  PMID: 29909853 BACKGROUND

• Milinis K, Thapar A, Shalhoub J, Davies AH. Antithrombotic Therapy Following Venous Stenting: International Delphi Consensus. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):537-544. doi: 10.1016/j.ejvs.2018.01.007. Epub 2018 Feb 12.

  PMID: 29449145 BACKGROUND

• Gurbel PA, Fox KAA, Tantry US, Ten Cate H, Weitz JI. Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease. Circulation. 2019 Apr 30;139(18):2170-2185. doi: 10.1161/CIRCULATIONAHA.118.033580.

  PMID: 31034291 BACKGROUND

• Langwieser N, Bernlochner I, Wustrow I, Dirschinger RJ, Jaitner J, Dommasch M, Bradaric C, Laugwitz KL, Ibrahim T. Combination of factor Xa inhibition and antiplatelet therapy after stenting in patients with iliofemoral post-thrombotic venous obstruction. Phlebology. 2016 Jul;31(6):430-7. doi: 10.1177/0268355515596289. Epub 2015 Jul 15.

  PMID: 26183668 BACKGROUND

• Endo M, Jahangiri Y, Horikawa M, Kaufman JA, Schenning RC, Kolbeck KJ, Barton RE, Ohuchi Y, Liang KW, Farsad K. Antiplatelet Therapy is Associated with Stent Patency After Iliocaval Venous Stenting. Cardiovasc Intervent Radiol. 2018 Nov;41(11):1691-1698. doi: 10.1007/s00270-018-2062-5. Epub 2018 Aug 17.

  PMID: 30120531 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; May-Thurner Syndrome

Interventions

Rivaroxaban; Anticoagulants; Aspirin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Peripheral Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hongkun Zhang, M.D.

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongkun Zhang, M.D.

CONTACT

0571-87236745; 1198050@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Vascular Surgery

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 5, 2021
• Study Start: November 3, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)