Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

NCT04967573 | Unknown Phase 3

• 1 other identifier: B2021-175R
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Individual component of primary outcomes (e.g. proximal extension, major bleeding)

  6 months

• Residual vein occlusion

  6 months

• Post-thrombotic syndrome

  6 months

• All-cause death

  6 months

Study Arms (2)

Prophylactic Anticoagulation

EXPERIMENTAL

Rivaroxaban 10 mg od for 3 months

Drug: Rivaroxaban

Therapeutic Anticoagulation

ACTIVE COMPARATOR

Rivaroxaban 20 mg od for 3 months

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Rivaroxaban 20 mg or 10 mg for 3 months

Prophylactic Anticoagulation; Therapeutic Anticoagulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (4)

Huadong Hospital affiliated to Fudan University

Shanghai, China

RECRUITING

Shanghai General Hospital

Shanghai, China

RECRUITING

Shanghai Wusong Hospital

Shanghai, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35228291 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhenyu Shi, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiguo Fu, PhD

CONTACT

17612117633; fu.weiguo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: August 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)