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Completed

NCT Number: NCT02926170

Rivaroxaban for Patients With Antiphospholipid Syndrome

Long-term anticoagulation is widely used for secondary thromboprophylaxis in the antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment. Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism and non valvular atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis in patients with APS compared with acenocoumarol

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Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

About this study

This is a phase 3 randomized, multicenter, non-inferiority open-label RCT. 190 eligible APS patients with arterial or venous thrombotic history receiving acenocoumarol will be stratified according the presence of SLE and venous/arterial thrombotic history and randomized (1:1) either to continue vitamin K antagonists (standard of care, normalized ratio (INR) 2-3 or 2.5 to 3.5 in those with recurrent thrombotic episodes) or to switch to rivaroxaban (20 mg/day). The primary efficacy outcome is the development of any thrombotic event during the study period. Secondary efficacy outcomes include time to thrombosis, type of thrombosis (arterial or venous), overall causes of death, evaluation of a prognostic biomarker panel of recurrent thrombosis. The primary safety outcome will be major bleeding. Secondary safety outcomes include any adverse event and minor bleeding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with thrombotic antiphsopholipd syndrome
  • Treated with acenocumarol for a minimum period of 6 months
  • Positivity for Lupus anticoagulant and/or anti-cardiolipin or anti-B2GPI antibodies IgG or IgM≥40

Exclusion criteria

  • Major haemorrhage (cerebral or gastrointestinal) within the previous 6 months
  • Neurosurgery within the previous 4 weeks
  • Any surgery within the previous 10 days
  • Active peptic ulcus
  • ALT or GPT >120 UI/mL non-lupus related in the previous 30 days
  • Platelets <30x10E9 in the previous 30 days
  • Recent diagnosed malignancy
  • Any criteria listed in the summary of the produt characterisitcs (SPC)
  • Renal disease with a creatinine clearance <30 mL/min or with a known uncontrolled renal disease
  • Concomitant administration of drugs that could interfere with CYP3A4

Treatment and study plan

Rivaroxaban

Drug

Rivaroxaban will be started at 20 mg/day. Dose will be adjusted according to Cr Clearance. Cr Clearance 30-49 ml/min will receive 15 mg/day.

Other names: XARELTO

acenocumarol

Drug

Doses will be adjusted according to INR

Other names: SINTROM

Primary outcomes

  1. Developement of a new thrombotic event (arterial or venous), confirmed by appropiate imaging studies

    Time frame: 36 months

    Stroke or transient ischemic attack, myocardial infarction, peripheral arterial thrombosis, cerebral vein thrombosis, deep-vein thrombosis, or pulmonary embolism) that was confirmed by adjudication

  2. Incidence of major bleeding

    Time frame: 36 months

    Major bleeding is defined as clinically overt bleeding associated with any of the following: fatal bleeding causing death, involvement of a critical anatomic site (intracranial, spinal, intraocular, pericardial, articular, retroperitoneal, or intramuscular with compartment syndrome) or need for surgery or angiographic intervention to stop haemorrhage, fall in haemoglobin concentration of at least 20 g/L in 24 hours, and/or requiring non-planned transfusion of ≥2 units of packed red blood cells or whole blood

Secondary outcomes

  1. Incidence of any treatment-Emergent Adverse events

    Time frame: 36 months

    i) all adverse events; ii) serious adverse events (SAE); iii) all bleeding events; iv) overall causes of death

  2. Death due to thrombotic events

    Time frame: 36 months

    Death as result of a thrombotic event

  3. Time to the first thrombotic event

    Time frame: 36 months

    Time (months) from the treatment onset up to the thrombotic event

  4. Location of thrombotic events

    Time frame: 36 months

    Location (arterial or venous) whenre the thrombotic event occurred

  5. Evaluation of a prognostic biomarker panel

    Time frame: 36 months

    Measuremnt of D-dimer, P-selectine and Von-willebrand factor

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Rivaroxaban Versus Acenocumarol for Secondary Thromboprophylaxis in Patients With Antiphospholipid Syndrome: a Randomized, Prospective, Phase III Study. Analysis of Stratification Prognostic Factors

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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