AMPLIFY-EXT (ELIQUIS® after the initial Management of Pulmonary embolIsm and deep vein thrombosis with First-line therapy-EXTended treatment) was designed to demonstrate the efficacy and safety of ELIQUIS® compared to placebo for the prevention of recurrent DVT and PE following six to 12 months of anticoagulant treatment for DVT and/or PE.1
VTE=Venous Thromboembolic Events
Eligible patients were those aged 18 years or older with objectively confirmed, symptomatic DVT or PE (with or without DVT); patients who had been treated for 6 to 12 months with standard anticoagulant therapy or had completed treatment with ELIQUIS® or enoxaparin/warfarin as participants in the AMPLIFY trial; and patients for whom there was clinical equipoise regarding the continuation or cessation of therapy.
Patients were excluded if they had a contraindication to continued anticoagulant therapy or if they required ongoing anticoagulant therapy, dual antiplatelet therapy, or ASA (Acetylsalicylic Acid) at a dose higher than 165 mg daily.
RRR = Relative Risk Reduction
*Only ELIQUIS® 2.5 mg BD is licensed for extended treatment.2
AMPLIFY-EXT: ELIQUIS® after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment.
Patients could have multiple risk factors.1
Data on the use of antiplatelet agents were calculated in the safety population (840 patients in the ELIQUIS® 2.5 mg group, 811 in the ELIQUIS® 5 mg group, and 826 in the placebo group), rather than the ITT (Intention To Treat) population.1