Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967573
• Other study ID #: B2021-175R
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Weiguo Fu, PhD
• Phone: 17612117633
• Email: fu.weiguo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 × 10? /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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban
Rivaroxaban 20 mg or 10 mg for 3 months

Locations

Country	Name	City	State
China	Huadong Hospital affiliated to Fudan University	Shanghai
China	Shanghai General Hospital	Shanghai
China	Shanghai Wusong Hospital	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographically confirmed recurrent venous thromboembolism	Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.	6 months
Primary	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	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
Secondary	Residual vein occlusion		6 months
Secondary	Post-thrombotic syndrome		6 months
Secondary	All-cause death		6 months