Clinical trial NCT04967573: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Venous Thrombosis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Radiographically confirmed recurrent venous thromboembolism
timeFrame: 6 months
measure: Major or clinically relevant non-major bleeding events
timeFrame: 3 months
Secondary outcomes:
measure: Individual component of primary outcomes (e.g. proximal extension, major bleeding)
timeFrame: 6 months
measure: Residual vein occlusion
timeFrame: 6 months
measure: Post-thrombotic syndrome
timeFrame: 6 months
measure: All-cause death
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong Hospital affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Shanghai Wusong Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Zhenyu Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.