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Siste oppdatering 08 april 2016
L.NO.MKT.03.2016.1478

Stroke Prevention in Atrial Fibrillation: ROCKET-AF

ROCKET-AF: Xarelto® versus warfarin

ROCKET-AF is a major outcomes study to compare the efficacy and safety of Xarelto® one tablet once daily with warfarin for the prevention of stroke and non–central nervous system systemic embolism in high-risk patients with non-valvular atrial fibrillation.15

Objectives and endpoints

The main objective of ROCKET-AF is to demonstrate that once daily Xarelto® is at least as effective as dose-adjusted warfarin for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation.
The primary efficacy endpoint is the composite endpoint of stroke and non–central nervous system systemic embolism.
The main safety endpoint is the composite of major and non-major clinically relevant bleeding events.15

Study design

ROCKET-AF is a prospective, randomised, double-blind, double-dummy, parallel-group, active-control, event-driven study in approximately 14,000 patients. The patients are randomly assigned to receive either:
  • Xarelto® 20 mg tablet once daily plus warfarin placebo once daily (15 mg tablet once daily plus warfarin placebo once daily for patients with moderate renal impairment at entry [creatinine clearance of 30–49 mL/min])
  • Warfarin once daily titrated to an INR of 2.5 (range 2–3) plus Xarelto® placebo once daily
In order to preserve blinding, all groups undergo routine coagulation monitoring as required with warfarin. The duration of treatment in each group is 12 to 32 months. The enrolled patients have a follow-up visit 30 days after the last dose of the study drug is given.15

 

  • 15 - A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation. Available at http://clinicaltrials.gov/ct2/show/NCT00403767. Accessed 13 August 2008.
Atrial fibrillation
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 dislodges from the upper chambers and becomes lodged in the brain.
Efficacy
The ability of a drug to produce the desired effect.
Composite endpoint
A combination of two or more endpoints in a clinical trial.
International Normalized Ratio
A system for assessing the clotting tendency of blood in patients receiving anticoagulant therapy. For patients with atrial fibrillation, the recommended target INR range is between 2 and 3. If the INR is higher than 3, patients are at risk of serious bleeding. If the INR is less than 2, patients are at risk of a blood clotting event.

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The overall Xarelto® study program will include about 50,000 patients. The studies to date establish Xarelto® as the most researched oral anticoagulant to date. 9

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