Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

Last updated: May 9, 2024
Sponsor: First Affiliated Hospital of Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Deep Vein Thrombosis

Venous Thrombosis

Treatment

Aspirin

Rivaroxaban

Clinical Study ID

NCT04694248
IIT20200040C
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: IC1. Subjects who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliacvenous stenosis (>50%). The ipsilateral iliac venous stenosis can be caused either by iliacvein compression (i.e. Cockett syndrome) or residue iliac venous thrombus afterpercutaneous mechanic thrombectomy. IC2. Subjects who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burdenof thrombus, with or without catheter directed thrombolysis (CDT). IC3. Subjects who accepted iliac venous stent(s) implantation during the perioperativeperiod of PMT or CDT (≤30 days post PMT or CDT) .

Exclusion

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 iliacvein. EC3. Subject has glomerular filtration rate < 60ml/min. EC4. Subject has ipsilateralvaricose vein or suffers from ipsilateral venous insufficiency prior to the DVT. Themanifestations 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 orgreater stenosis at abdominal aorta, ipsilateral iliac artery and ipsilateral lowerextremity 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 hassystemic disease(s) that cannot be treated by current medicine. EC9. Subject has been taking anticoagulants or antiplatelet drugs for other diseases priorto the DVT. EC10. Subject less than 18 years old or rejected to join this study. EC11. Subject hasmyocardial infarction during the past 6 months. EC12. EC12. Subject who is at high bleedingrisk*.

  • Subject who has at least one of the below conditions will be considered at high bleedingrisk: Primary history of intracerebral haemorrhage or ischemic stroke, history of otherintracranial pathology, recent gastrointestinal bleeding or anaemia due to possiblegastrointestinal blood loss, other gastrointestinal pathology associated with increasedbleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age orfrailty, or renal failure requiring dialysis or with eGFR <15ml/min/1.73 m2.

Study Design

Total Participants: 172
Treatment Group(s): 2
Primary Treatment: Aspirin
Phase:
Study Start date:
November 03, 2021
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

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

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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