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Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

Primary Purpose

Venous Thrombosis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rivaroxaban
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thrombosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huadong Hospital affiliated to Fudan UniversityRecruiting
  • Shanghai General HospitalRecruiting
  • Shanghai Wusong HospitalRecruiting
  • Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prophylactic Anticoagulation

Therapeutic Anticoagulation

Arm Description

Rivaroxaban 10 mg od for 3 months

Rivaroxaban 20 mg od for 3 months

Outcomes

Primary Outcome Measures

Radiographically confirmed recurrent venous thromboembolism
Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.
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.

Secondary Outcome Measures

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.
Residual vein occlusion
Post-thrombotic syndrome
All-cause death

Full Information

First Posted
July 8, 2021
Last Updated
February 10, 2022
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04967573
Brief Title
Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis
Official Title
Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis (IDENT): a Prospective, Multicenter, Single-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic Anticoagulation
Arm Type
Experimental
Arm Description
Rivaroxaban 10 mg od for 3 months
Arm Title
Therapeutic Anticoagulation
Arm Type
Active Comparator
Arm Description
Rivaroxaban 20 mg od for 3 months
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
Rivaroxaban 20 mg or 10 mg for 3 months
Primary Outcome Measure Information:
Title
Radiographically confirmed recurrent venous thromboembolism
Description
Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.
Time Frame
6 months
Title
Major or clinically relevant non-major bleeding events
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Individual component of primary outcomes (e.g. proximal extension, major bleeding)
Description
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.
Time Frame
6 months
Title
Residual vein occlusion
Time Frame
6 months
Title
Post-thrombotic syndrome
Time Frame
6 months
Title
All-cause death
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiguo Fu, PhD
Phone
17612117633
Email
fu.weiguo@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenyu Shi, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huadong Hospital affiliated to Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Zhang, PhD
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieqi Mao, PhD
Facility Name
Shanghai Wusong Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yucheng Zhang, MD
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Shi, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35228291
Citation
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.
Results Reference
derived

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Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

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