An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures

CompletadoFase 3ClinicalTrials.gov

ID: NCT02504216Tipo: INTERVENTIONALInicio: 18 de ago de 2015Fin estimado: 9 de ene de 2020

Traducción no disponible, mostrando original

Resumen

The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Age ≥50
Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease
Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization

Criterios de exclusión

Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis.
Prior revascularization on the index leg within 10 days of the qualifying revascularization.
Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for \>6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use.
Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.

Intervenciones

drug

Rivaroxaban (Xarelto, BAY59-7939)

2.5 mg, twice daily, orally, tablet

drug

Rivaroxaban-Placebo

matching placebo, twice daily, orally, tablet

Ubicaciones

Bahía Blanca, Buenos Aires, Argentina

Ciudadela, Buenos Aires, Argentina

Coronel Suárez, Buenos Aires, Argentina

Junín, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

San Isidro, Buenos Aires, Argentina

San Martín, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Santa Rosa, La Pampa Province, Argentina

Rosario, Santa Fe Province, Argentina

Ciudad Auton. de Buenos Aires, Argentina

Corrientes, Argentina

Córdoba, Argentina

Santa Fe, Argentina

Patrocinadores

PrincipalBayer

ColaboradorJanssen Research & Development, LLC

ColaboradorColorado Prevention Center

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