Edoxaban for the Management of Elderly Japanese Patients with Atrial Fibrillation Ineligible for Standard Oral Anticoagulant Therapies: Rationale and Design of the ELDERCARE-AF Study

Publication date: Available online 24 August 2017 Source:American Heart Journal Author(s): Ken Okumura, Gregory Y.H. Lip, Masaharu Akao, Kimihiko Tanizawa, Masayuki Fukuzawa, Kenji Abe, Masahiro Akishita, Takeshi Yamashita Edoxaban—a nonvitamin K antagonist oral anticoagulant (NOAC)— 60-mg and 30-mg once-daily dose regimens are noninferior vs well-managed warfarin for the prevention of stroke or systemic embolic events (SEE) with less major bleeding in patients with nonvalvular atrial fibrillation (NVAF). There are no published data from phase 3 clinical trials specifically evaluating the use of NOACs in elderly NVAF patients, especially those considered ineligible for available oral anticoagulants. The Edoxaban Low-Dose for EldeR CARE AF patients (ELDERCARE-AF) study is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study that will compare the safety and efficacy of once-daily edoxaban 15mg vs placebo in Japanese patients with NVAF ≥80years of age who are considered ineligible for standard oral anticoagulant therapy. A total of 800 patients (400 in each treatment group) are planned for randomization (1:1) to either edoxaban or placebo using a stratified randomization method with CHADS2 index score (2 points, ≥3 points) as a factor. The primary efficacy endpoint is the time to first onset of stroke or SEE. The net clinical outcome is the composite of stroke, SEE, major bleeding, and all-cause mortality. The primary safet...
Source: American Heart Journal - Category: Cardiology Source Type: research