Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Thrombosis
• Intervention / Treatment: Drug: Rivaroxaban

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Weiguo Fu, PhD; Phone Number: 17612117633; Email: fu.weiguo@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai General Hospital
    • Contact: Jieqi Mao, PhD
  • Shanghai, China
    • Recruiting
    • Huadong Hospital Affiliated to Fudan University
    • Contact: Wan Zhang, PhD
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital, Fudan University
  • Shanghai, China
    • Recruiting
    • Shanghai Wusong Hospital
    • Contact: Yucheng Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Any absolute contraindication to anticoagulant treatment
• Pregnancy or breast-feeding
• Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg
• Platelet count < 100 × 10⁹ /L
• Serum creatinine > 180 mmol/L or creatinine clearance ≤30 ml/min
• Liver disease associated with coagulopathy and high risk of bleeding
• Clinically suspected or confirmed pulmonary embolism
• Ipsilateral or contralateral proximal DVT
• Any indication for long-term anticoagulation
• Enrolled in another clinical trial simultaneously
• Life expectancy < 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prophylactic Anticoagulation; Rivaroxaban 10 mg od for 3 months	Drug: Rivaroxaban; Rivaroxaban 20 mg or 10 mg for 3 months
ACTIVE_COMPARATOR: Therapeutic Anticoagulation; Rivaroxaban 20 mg od for 3 months	Drug: Rivaroxaban; Rivaroxaban 20 mg or 10 mg for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographically confirmed recurrent venous thromboembolism	Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.	6 months
Major or clinically relevant non-major bleeding events	Major bleeding events are defined according to the International Society on Thrombosis and Haemostasis criteria. Clinically relevant non-major bleeding events refer to which do not meet the mentioned criteria of major bleeding but need at least an unscheduled in-person consultant.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-thrombotic syndrome		6 months
Individual component of primary outcomes (e.g. proximal extension, major bleeding)	Individual component of primary outcomes, including proximal extension of isolated distal DVT, new contralateral proximal DVT, new pulmonary embolism, major bleeding events, clinically relevant non-major bleeding events.	6 months
Residual vein occlusion		6 months
All-cause death		6 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• Zhou M, Zhang W, Zhang Y, Xie T, Mao J, Shi Z. Therapeutic or prophylactic anticoagulation in acute isolated distal deep vein thrombosis: protocol for a prospective, multicentre, single-blind, randomised controlled trial (TOP-IDDVT). BMJ Open. 2022 Feb 28;12(2):e056826. doi: 10.1136/bmjopen-2021-056826.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (ACTUAL): July 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: B2021-175R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No