Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events
Condition: Venous Thromboembolism; Anticoagulant-induced Bleeding; Venous Thromboses; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Venous thromboembolism affects around 10 million people per year worldwide, however, despite
      its high incidence, there is no systematic review or randomized trial focused on the
      treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism
      (PE) during anticoagulant treatment. The objective was to compare the use of Rivaroxaban plus
      Aspirin versus Acenocoumarol in patients with recurrent venous thromboembolism treated with
      rivaroxaban.
    

Detailed description: 
      Venous thromboembolism has two manifestations, deep vein thrombosis (DVT) and pulmonary
      embolism (PE), affects around 10 million people per year worldwide, with an annual incidence
      of 1-2 cases per 1000 population and increases exponentially with age. [1,2,3] DVT is a
      multicausal disease thought to be triggered by interactions between multiple triggering
      factors that may be additive or synergistic, such as active cancer, antiphospholipid syndrome
      (APS), or other chronic inflammatory disorders. [2,4] The contribution of genetics to the
      risk of thromboembolism venous traditionally includes protein C, protein S, and antithrombin
      deficiencies, prothrombin gene mutation, and factor V Leiden. [5] The exact epidemiology in
      Mexico is unknown, however, the estimated prevalence of deficiencies in a population studied
      in Mexico City were Protein C (PC) 0.65%, Protein S (PS) 0.65%, Antithrombin (AT) 2.04% and
      Plasminogen ( Plg) 2.5%. [6] For the treatment of patients with DVT and/or PE, the American
      Society of Hematology (ASH) guideline panel suggests using direct oral anticuagulants (DOACs)
      over vitamin K antagonists (VKAs), [7] however the use of a DOAC instead of a VKA for
      patients with DVT does not impact mortality, the use of DOACs has also been related to a
      reduction in the risk of DVT and major bleeding, although this was not statistically
      significant, the greatest advantage is that the use of DOACs do not require frequent dose
      adjustment, monitoring of the INR, or dietary restrictions, [8 -31] in our work center we
      started with DOACs as the first line of treatment.

      Recurrent DVT despite anticoagulation has been related to the presence of active cancer,
      subtherapeutic anticoagulation, use of concomitant anticancer drugs, younger age at
      presentation (<65 years), and PE as the initial DVT. [32-40] Insertion of an inferior vena
      cava (IVC) filter was previously recommended in patients with recurrent DVT while receiving
      anticoagulant therapy. [41] However, the risk of recurrent DVT after IVC filter insertion is
      as high as 32% in cancer patients and has been associated with significant morbidity and poor
      quality of life; [42-46] It has been suggested that increasing the dose of low molecular
      weight heparin (LMWH) may be an alternative to IVC filter insertion in patients with
      recurrent DVT, [47-49] however, to date, there is no systematic review or randomized trial
      focused on the treatment of patients with recurrent DVT and/or PE during anticoagulant
      treatment.

      The aim of the current study was to compare the use of Rivaroxaban plus Aspirin versus
      Acenocoumarol in the prevention of thromboembolic and bleeding events in patients with
      recurrent venous thromboembolism treated with rivaroxaban.
    

Intervention name(s): Rivaroxaban 20 MG [Xarelto]; Aspirin 300mg; Acenocoumarol Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization); It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization); It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
Other intervention name(s): Xarelto 20 mg; Acetilsalicilic acid; Vitamin K antagonist
Intervention MeSH terms: Aspirin; Vitamin K; Rivaroxaban; Acenocoumarol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: venous thromboembolism; Rivaroxaban; Aspirin; Acenocoumarol