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Therapeutic or prophylactic anticoagulation in acute isolated distal deep vein thrombosis: protocol for a

Min Zhou1, Wan Zhang2, Yucheng Zhang3

  • 1Department of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, China.

BMJ Open
|March 1, 2022
PubMed

Insights

This study compares therapeutic versus prophylactic rivaroxaban for acute symptomatic isolated distal deep vein thrombosis (IDDVT). It assesses efficacy in preventing recurrent venous thromboembolism and safety regarding bleeding events in IDDVT patients.

Area of Science:

  • Cardiology
  • Vascular Medicine
  • Pharmacology

Background:

  • Efficacy and safety of anticoagulant treatment for acute symptomatic isolated distal deep vein thrombosis (IDDVT) are not established.
  • Real-world practice varies between therapeutic and prophylactic anticoagulation for IDDVT.
  • Therapeutic anticoagulation carries a higher bleeding risk than prophylactic anticoagulation.

Purpose of the Study:

  • To assess the efficacy and safety of therapeutic versus prophylactic anticoagulation with rivaroxaban in patients with first acute symptomatic IDDVT.
  • To compare rivaroxaban 20 mg once daily (therapeutic) versus 10 mg once daily (prophylactic) for 3 months.

Main Methods:

  • Prospective, multicentre, single-blind, randomised controlled trial (NCT04967573).
  • Recruitment of outpatients with first acute symptomatic IDDVT from August 2021.
  • 1:1 randomization to prophylactic (10 mg/day) or therapeutic (20 mg/day) rivaroxaban for 3 months, with 6-month follow-up.

Main Results:

  • Primary efficacy outcome: radiographically confirmed recurrent venous thromboembolism.
  • Primary safety outcome: incidence of major or clinically relevant non-major bleeding events.
  • Study results will be disseminated through peer-reviewed journals.

Conclusions:

  • The study will provide crucial data on the optimal anticoagulation strategy for IDDVT.
  • Findings will inform clinical practice guidelines for managing this specific patient population.
  • This research addresses an unmet need in understanding IDDVT treatment outcomes.
Abstract

Keywords:
anticoagulationthromboembolismvascular surgery

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