X-VeRT

EXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of caRdiovascular events in subjects with non-valvular aTrial fibrillation scheduled for cardioversion (2013, ongoing)

Condition

Prevention of cardiovascular events in patients with non-valvular atrial fibrillation scheduled for cardioversion

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Objective

To explore whether rivaroxaban, as compared to vitamin K antagonists (VKA), can effectively prevent cardiovascular events in patients with non-valvular AF undergoing cardioversion

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Trial design

Prospective, randomized, open-label, parallel-group, active-controlled phase III study
Active treatment: rivaroxaban 20 mg p.o. once daily, 15 mg once daily in patients with moderate renal impairment
Control treatment: VKA orally once daily, titrated to a target international normalized ratio (INR) of 2.0–3.0.The VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards
Duration of anticoagulant treatment depends on strategy:

  • Direct cardioversion strategy if sufficient anticoagulation is proven during the last 21 days prior to randomization: rivaroxaban/VKA for 1–5 days before cardioversion and continued for 42 days after the cardioversion
  • Delayed cardioversion strategy if sufficient anticoagulation is not proven during the last 21 days prior to randomization: rivaroxaban/VKA for at least 21 (+4) to a maximum of 56 (+4) days prior to planned cardioversion and continued for 42 days after the cardioversion

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Endpoints

Primary efficacy endpoint: composite of stroke, transient ischemic attack, non-central nervous system systemic embolism, myocardial infarction and cardiovascular death
Primary safety endpoint: major bleedings
Secondary outcome measures: number of strokes, transient ischemic attacks, non-central nervous system systemic embolisms, myocardial infarctions, cardiovascular deaths, all-cause mortality, major and non-major bleeding events

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Trial participants

~1,500 patients ≥18 years with hemodynamically stable non-valvular atrial fibrillation longer than 48 hours or of unknown duration, scheduled for cardioversion (electrical or pharmacological)

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Reference

ClinicalTrials.gov (NCT01674647)

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