虚血性脳卒中患者および経口抗凝固薬の直接服用患者における静脈内血栓溶解療法の安全性と有効性

基本情報

NCT ID

NCT06571149

ステータス

募集中

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

906

治験依頼者名

Insel Gruppe AG, University Hospital Bern

概要

DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)