Eliquis (Apixaban) Clinical Trials
The approved indications for ELIQUIS are based on a robust
clinical trial programme1–7
Learn more about ELIQUIS in NVAF and
DVT / PE.
Pivotal clinical trial in NVAF: ARISTOTLE
In the ARISTOTLE trial, ELIQUIS demonstrated superior stroke / systemic embolism prevention with significantly less major bleeding vs. warfarin in patients with NVAF.4
Adapted from Granger et al. 2011.4
* ARISTOTLE: Phase III trial, with a total of 18,201 patients with NVAF and ≥1 risk factor for stroke and a mean CHADS2 score of 2.1 randomised to ELIQUIS 5 mg BD (or 2.5 mg BD in selected patients [4.7%]) or warfarin adjusted to target INR range 2.0–3.0, for a median of 1.8 years. A 2.5 mg BD dose of ELIQUIS was used in patients who met two or more of the following criteria: ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dl (133 µmol/l). Patients with the exclusive criteria of severe renal impairment (creatinine clearance 15–29 ml/min) should also receive a lower dose of 2.5 mg twice daily. Stroke or systemic embolism was the primary efficacy endpoint of the ARISTOTLE trial (haemorrhagic stroke and ischaemic or undetermined stroke were components of stroke) and major bleeding defined per International Society on Thrombosis and Haemostasis (ISTH) criteria was the primary safety endpoint. Efficacy analyses based on ITT population. Safety analyses based on patients who had at least one dose of study drug.4
View the full overview of study design and results from the ARISTOTLE trial.
432UK1800479-01 – May 2018
Pivotal clinical trials in DVT / PE: AMPLIFY and AMPLIFY-EXT
In the AMPLIFY trial, ELIQUIS demonstrated both comparable efficacy and significantly less major bleeding vs. standard of care (enoxaparin / warfarin) in the treatment of
DVT / PE.6
Adapted from Agnelli et al. 2013.6
† AMPLIFY: Phase III, randomised, double-blind trial in 5,395 patients with DVT and / or PE. The duration of the trial was 6 months. The primary efficacy endpoint was the rate of recurrent VTE / VTE-related death vs. enoxaparin / warfarin. Efficacy analyses based on ITT population for whom the outcome status at 6 months was documented; safety analyses based on patients who had at least one dose of study drug.6
View the full overview of study design and results from the AMPLIFY trial.
432UK1800479-02 – May 2018
In the AMPLIFY-EXT trial, extended treatment with ELIQUIS 2.5 mg BD demonstrated superior efficacy and a
comparable bleeding profile
vs. placebo.7
Adapted from the ELIQUIS SmPC1 and Agnelli et al. 2013.7
‡ AMPLIFY-EXT: Phase III, randomised, double-blind trial in 2,482 patients with DVT or PE who had completed 6 to 12 months of anticoagulation therapy. The duration of the trial was 12 months. Efficacy analyses based on ITT population for whom the outcome status at 12 months was documented; safety analyses based on patients who had at least one dose of study drug.7
View the full overview of study design and results from the AMPLIFY-EXT trial.
432UK1800479-03 – May 2018
Please click here to access the ELIQUIS Patient Information Leaflet.
AMPLIFY = Apixaban for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-Line Therapy
AMPLIFY-EXT = Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy–Extended Treatment
ARISTOTLE = Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation
ARR = Absolute Risk Reduction
BD = Twice Daily
CI = Confidence Interval
DVT = Deep Vein Thrombosis
HR = Hazard Ratio
ITT = Intention to Treat
INR = International Normalised Ratio
n = number of patients with event
NS = Not Significant
NVAF = Non-Valvular Atrial Fibrillation
PE = Pulmonary Embolism
RR = Relative Risk
RRR = Relative Risk Reduction
VTE = Venous Thromboembolic Events
References
- ELIQUIS® (apixaban) Summary of Product Characteristics.
- Lassen MR et al. Lancet 2010; 375: 807–815.
- Lassen MR et al. N Engl J Med 2010; 363: 2487–2498.
- Granger CB et al. N Engl J Med 2011; 365: 981–992.
- Connolly SJ et al. N Engl J Med 2011; 364: 806–817.
- Agnelli G et al. N Engl J Med 2013; 369: 799–808.
- Agnelli G et al. N Engl J Med 2013; 368: 699–708.