虚血性脳卒中後心房細動患者における直接経口抗凝固薬の早期投与と後期投与の比較（ELAN）：国際多施設共同無作為化比較試験（2群、評価者盲検）

基本情報

NCT ID: NCT03148457
ステータス: 完了
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 2,013
治験依頼者名: Insel Gruppe AG, University Hospital Bern

概要

When to start anticoagulation in patients with an acute ischaemic stroke and atrial fibrillation (AF) is a relevant unanswered question in clinical practice. Direct oral anticoagulants (DOACs) are highly effective for secondary stroke prevention in these patients, but DOACs were never initiated \<7 days after stroke onset in recent trials. The ELAN trial will determine the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation.

対象疾患

Ischaemic Stroke

介入

Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)(DRUG)

Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)(DRUG)

依頼者（Sponsor）

Insel Gruppe Ag, University Hospital Bern(OTHER)

実施施設 (10)

Kumamoto University

Kumamoto, Japan

Kumamoto University

Kumamoto, Japan

国立研究開発法人　国立循環器病研究センター

Osaka, Japan

Kansai Medical University

Hirakata, Japan

Jichi Medical University

Tochigi, Japan

St. Marianna Medical University Hospital

Kawasaki, Japan