Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis (IDENT): a Prospective, Multicenter, Single-blind, Randomized Controlled Trial

Who is this study for? Patients with Venous Thrombosis
What treatments are being studied? Rivaroxaban
Status: Unknown
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute IDDVT. However, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. Thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic IDDVT of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Patients aged 18-90

• Outpatients with a first, acute (within 2 weeks), symptomatic, objectively confirmed isolated distal DVT

• Compliance to the scheduled follow up plan

• Ability and willing to participate and sign the informed consent.

Locations
Other Locations
China
Huadong Hospital affiliated to Fudan University
RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Shanghai Wusong Hospital
RECRUITING
Shanghai
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Weiguo Fu, PhD
fu.weiguo@zs-hospital.sh.cn
17612117633
Time Frame
Start Date: 2021-08-01
Completion Date: 2023-12-31
Participants
Target number of participants: 480
Treatments
Experimental: Prophylactic Anticoagulation
Rivaroxaban 10 mg od for 3 months
Active_comparator: Therapeutic Anticoagulation
Rivaroxaban 20 mg od for 3 months
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov