Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04967573

Collaborator

(none)

480

Enrollment

Locations

Arms

Anticipated Duration (Months)

120

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thrombosis	Drug: Rivaroxaban	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Radiographically confirmed recurrent venous thromboembolism [6 months]
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 [3 months]
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) [6 months]
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 [6 months]
Post-thrombotic syndrome [6 months]
All-cause death [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Huadong Hospital affiliated to Fudan University	Shanghai	China
2	Shanghai General Hospital	Shanghai	China
3	Shanghai Wusong Hospital	Shanghai	China
4	Zhongshan Hospital, Fudan University	Shanghai	China

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

Principal Investigator: Zhenyu Shi, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT04967573

Other Study ID Numbers:

B2021-175R

First Posted:

Jul 19, 2021

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombosis

Venous Thrombosis

Rivaroxaban

Study Results

No Results Posted as of Feb 16, 2022