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Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
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ROCKET AF: Stroke Prevention in Atrial Fibrillation

Major Studies

 

ROCKET AF:
rivaroxaban for stroke prevention in atrial fibrillation 

  • Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and it markedly increases the risk of stroke

  • Additional risk factors such as age, gender and concomitant medical conditions (including heart failure and diabetes mellitus) further exacerbate the risk of stroke

  • Vitamin K antagonists, such as warfarin and acenocoumarol, are the current standard of care for stroke prevention in AF but are challenging to manage in clinical practice

  • Although effective, vitamin K antagonists have an unpredictable pharmacological profile that necessitates routine coagulation monitoring and dose adjustment to ensure that patients remain within the therapeutic range

    • Despite guidelines, less than 54% of patients with AF who need anticoagulation receive it

    • Only 1 in 10 patients with AF is adequately anticoagulated at the time of first stroke
       

ROCKET AF: once-daily rivaroxaban versus dose-adjusted warfarin

ROCKET AF compared the efficacy and safety of once-daily rivaroxaban with warfarin for the prevention of stroke and systemic embolism in patients with non-valvular AF for whom guidelines recommend oral anticoagulation.


Objective

The main objective of ROCKET AF was to determine if once-daily rivaroxaban was as effective as dose-adjusted warfarin for the prevention of thromboembolic events in patients with non-valvular AF who are at increased risk of stroke.
 

Study Design

ROCKET AF was a prospective, randomised, double-blind, multicentre, parallel-group, active-control, event-driven study of 14,264 patients with non-valvular AF and a history of stroke, TIA or systemic embolism or with at least two risk factors for stroke. The patients were randomised to receive either:

  • Rivaroxaban 20 mg once-daily (15 mg once-daily for patients with moderate renal impairment at entry [creatinine clearance of 30–49 ml/min])

  • Warfarin titrated to an international normalised ratio of 2.5 (range 2.0–3.0)

To preserve blinding, all groups underwent routine coagulation monitoring as required with warfarin. Sham international normalised ratio values were provided for patients receiving rivaroxaban.

Rocket af study design pu

Inclusion criteria

The study was designed to evaluate a moderate-to-high risk adult patient population with persistent or paroxysmal AF and either:

  • Prior stroke, transient ischaemic attack or systemic embolism; or

  • Two or more risk factors for stroke including: clinical heart failure and/or left ventricular ejection fraction ≤35%, hypertension, age ≥75 years or diabetes mellitus

  • Patients with only two risk factors for stroke were capped at 10% of the overall trial population, with the remaining patients requiring three or more risk factors, or a prior stroke, transient ischaemic attack or systemic embolism
     

Study endpoints

  • The primary efficacy endpoint was the composite endpoint of stroke (ischaemic or haemorrhagic) and systemic embolism

  • The principal safety outcome was the composite of major and non-major clinically relevant bleeding
     

PP-XAR-ALL-1821-1

    • 1
      National Heart Lung and Blood Institute. Atrial Fibrillation. 2009. [accessed 19 November 2019].
    • 2
      Wolf PA, et al. Stroke. 1991;22:983–988.
    • 3
      Go AS, et al. JAMA 2001;285:2370–2375.
    • 4
      Heeringa J, et al. Eur Heart J. 2006;27:949–953.
    • 5
      Benjamin EJ, et al. JAMA. 1994;271:840–844.
    • 6
      Verheugt FW. Neth Heart J. 2010;18:314–318.
    • 7
      Ansell J, et al. Chest. 2008;133:160S–198S.
    • 8
      Gladstone DJ, et al. Stroke. 2009;40:235–240.
    • 9
      Waldo AL, et al. J Am Coll Cardiol. 2005;46:1729–1736.
    • 10
      Patel MR, et al. N Engl J Med. 2011;365:883–891.
    • a
      Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot… 
    • b
      Transient ischaemic attack (= TIA). Also known as a ‘mini stroke’. This is caused by a temporary disruption in the blood supply to part of the brain.