Rivaroxaban for Patients With Antiphospholipid Syndrome

NCT02926170 | Completed Phase 3 DMC

• 1 other identifier: 2010-019764-36
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antiphospholipid Syndrome

Outcome Measures

Primary Outcomes (2)

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

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

  36 months

• Incidence of major bleeding

  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

  36 months

Secondary Outcomes (5)

• Incidence of any treatment-Emergent Adverse events

  36 months

• Death due to thrombotic events

  36 months

• Time to the first thrombotic event

  36 months

• Location of thrombotic events

  36 months

• Evaluation of a prognostic biomarker panel

  36 months

Study Arms (2)

rivaroxaban

EXPERIMENTAL

Rivaroxaban 20 mg per day

Drug: Rivaroxaban

acenocumarol

ACTIVE COMPARATOR

INR adjusted dose

Drug: acenocumarol

Interventions

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.

Also known as: XARELTO

rivaroxaban

acenocumarol DRUG

Doses will be adjusted according to INR

Also known as: SINTROM

acenocumarol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Rivaroxaban; Acenocoumarol

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Josefina Cortes, MD,pHD

  Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 6, 2016
• Study Start: March 13, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

ES (1)