PIONEER AF-PCI

Study exploring two strategies of rivaroxaban and one of oral vitamin K antagonists in patients with atrial fibrillation who undergo percutaneous coronary intervention (2013, ongoing)

Condition

Non-valvular AF requiring anticoagulation for stroke prevention and overlapping acute coronary syndrome requiring stenting and dual antiplatelet therapy

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Objective

The primary purpose of this study is to evaluate the safety of two different rivaroxaban treatment strategies and one vitamin K antagonist treatment strategy utilizing various combinations of dual antiplatelet therapy or lowdose aspirin or clopidogrel (or prasugrel or ticagrelor) in patients with paroxysmal, persistent, or permanent non-valvular AF who undergo PCI with stent placement

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Trial design

Randomized, controlled phase IIIb clinical study with a 12-month open-label treatment phase

Active treatment:

  • double antithrombotic therapy: rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus a P2Y12 inhibitor (such as clopidogrel 75 mg once daily or prasugrel 10 mg once daily or ticagrelor 90 mg twice daily) for 12 months (n= ~700)
  • triple antithrombotic therapy: rivaroxaban 2.5 mg p.o. twice daily plus dual antiplatelet therapy with aspirin (ASA) 75–100 mg once daily and a P2Y12 inhibitor (such as clopidogrel 75 mg once daily or prasugrel 10 mg once daily or ticagrelor 90 mg twice daily) followed by rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ASA 75–100 mg/d for 12 months (n= ~700)

Control treatment:

  • triple antithrombotic therapy: dose-adjusted vitamin K antagonist (VKA) once daily (target INR 2.0–3.0) plus dual antiplatelet therapy with ASA 75–100 mg/d and a P2Y12 inhibitor (such as clopidogrel 75 mg once daily or prasugrel 10 mg once daily or ticagrelor 90 mg twice daily) followed by dose-adjusted VKA once daily (target INR 2.0–3.0 or 2.0–2.5 at the investigator’s discretion) plus ASA 75–100 mg/d for 12 months (n= ~700)

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Endpoints

Primary outcome measure: number of participants with clinically significant bleeding (composite of major bleeding, minor bleeding, and bleeding requiring medical attention)

Secondary outcome measures:

  • number of participants with clinically significant bleeding events
  • number of participants with adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, stent thrombosis)
  • number of participants with other adverse events
  • composite of clinically significant bleeding and adverse cardiovascular
    events

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Trial participants

The study will enroll approximately 2100 patients with atrial fibrillation requiring anticoagulant therapy for stroke prevention and who have undergone a percutaneous coronary intervention procedure with stent placement and therefore requiring dual antiplatelet therapy

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Reference

ClinicalTrials.gov (NCT01830543)

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Corresponding author

C. Michael Gibson, MD, FACC, Harvard Medical School, Division of Cardiology, Deaconess 319, 185 Pilgrim Rd, Boston, MA 02115, United States, email: mgibson@perfuse.org

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