Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    172
  • sponsor
    First Affiliated Hospital of Zhejiang University
Updated on 22 December 2021
stenosis
aspirin
clot
antiplatelet therapy
rivaroxaban
thrombectomy
blood clot
dvts

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.

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.

Details
Condition Deep Vein Thrombosis, Iliac Vein Thrombosis, Iliac Vein Obstruction, Iliac Vein Stenosis, Iliac Vein Compression Syndrome
Treatment Aspirin, Rivaroxaban
Clinical Study IdentifierNCT04694248
SponsorFirst Affiliated Hospital of Zhejiang University
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

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
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