X-PLORER

Exploring the efficacy and safety of rivaroxaban to support elective percutaneous coronary intervention (2013, ongoing)

Condition

Prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease

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Objective

To explore whether rivaroxaban, as compared to unfractionated heparin (UFH), on the background of standard dual antiplatelet therapy, can effectively suppress thrombosis and related adverse ischemic events, upon balloon inflation and stent expansion, during elective PCI, without increasing bleeding

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Trial design

Prospective, randomized, heparin-controlled dose-finding trial, semi-blinded design: no blinding for randomization either to rivaroxaban (one of the 3 arms) or the control (UFH) group. However, all will be blinded for the treatment dose of rivaroxaban (either 10 mg or 20 mg); the 10 mg rivaroxaban plus 50 IU UFH arm will not be blinded

Active treatment:

  • Stratum 1: rivaroxaban 10 mg p.o. single dose
  • Stratum 2: rivaroxaban 20 mg p.o. single dose
  • Stratum 3: rivaroxaban 10 mg p.o. single dose followed by a bolus of 50 IU/kg UFH

Control treatment: UFH: 70–100 IU/kg bolus i.v. and adjusted upon activated coagulation time (ACT) of 250–300 seconds

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Endpoints

Primary efficacy endpoints: percentage of subjects who

  • require bail-out anticoagulant therapy in the context of an ischemic coronary event
  • experience an angiographic flow limiting thrombotic event
  • experience thrombus formation on the PCI equipment
  • experience a myocardial infarction due to PCI

Secondary outcome measures: bleeding, composite of clinical ischemic events (all-cause death, non-fatal myocardial infarction, non-fatal stroke and target lesion revascularization)

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Trial participants

106 patients ≥18 years with symptomatic coronary artery disease due to undergo an elective (non-emergent) PCI on one or two lesions in the native coronary vessel(s); cardiac standard troponin at baseline has to be within the normal limits

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Reference

ClinicalTrials.gov (NCT01442792)

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