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Background <p>Cardioembolic stroke accounts for more than 20% of all acute ischemic strokes (AIS) and is mainly caused by cardiac arrhythmias, particularly atrial fibrillation (AF). The presence of specific or multiple additional vascular risk factors indicates the need for oral anticoagulant (OAC) therapy in AF patients (according to the CHA2DS2-VASc classification). While OAC treatment significantly reduces the risk of AIS by over 80% in this population, the risk remains higher compared to the general population. Approximately half of AF patients on OAC therapy who experience AIS do not meet the criteria for thrombolytic (high blood activity of OAC) or mechanical thrombectomy (non-large vessel occlusion stroke) treatment.</p> Aim <p>This study aims to assess the efficacy and safety of recombinant tissue plasminogen activator (rtPA) in AIS patients who have been on chronic non-vitamin K antagonist oral anticoagulant (DOAC) therapy after receiving a specific reversal agent.</p> Methods and design <p>Patients with acute ischemic stroke (AIS) who are treated with specific oral anticoagulants (OACs) with anti-Xa activity have been on chronic non-vitamin K antagonist oral anticoagulant e included in the study. The protocol involves administering a fast-acting antidote (andexanet alfa for rivaroxaban or apixaban) or a placebo, followed by intravenous thrombolytic therapy with rtPA or a placebo. The study arms for rivaroxaban and apixaban are designed as prospective, randomized, placebo-controlled interventional trials that meet phase II trial criteria.</p> Discussion <p>The STRoke on Oral AntiCoagulants for Thrombolysis (STROACT) trial is, to our knowledge, the first randomized phase II study designed to explore the feasibility, efficacy, and safety of reversal-enabled intravenous thrombolysis in a highly selected population of acute ischemic stroke patients on factor Xa inhibitors. The results are expected to be hypothesis-generating and may inform the design of future confirmatory trials.</p> Trial registration <p><a href="http://www.clinicaltrialsregister.eu">www.clinicaltrialsregister.eu</a>; EudraCT Nr: 2020–004898–41; March 31, 2021.</p>

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Reperfusion thrombolytic therapy for ischemic stroke in patients on non-vitamin K antagonist oral anticoagulants: study protocol of a phase II randomized clinical trial

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  • 发表日期：

    2026年5月7日

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  • Bartosz Karaszewski,
  • Bartosz Jabłoński,
  • Dariusz Gąsecki,
  • Sebastian Szczyrba,
  • Adam Wyszomirski

摘要

Background

Cardioembolic stroke accounts for more than 20% of all acute ischemic strokes (AIS) and is mainly caused by cardiac arrhythmias, particularly atrial fibrillation (AF). The presence of specific or multiple additional vascular risk factors indicates the need for oral anticoagulant (OAC) therapy in AF patients (according to the CHA2DS2-VASc classification). While OAC treatment significantly reduces the risk of AIS by over 80% in this population, the risk remains higher compared to the general population. Approximately half of AF patients on OAC therapy who experience AIS do not meet the criteria for thrombolytic (high blood activity of OAC) or mechanical thrombectomy (non-large vessel occlusion stroke) treatment.

Aim

This study aims to assess the efficacy and safety of recombinant tissue plasminogen activator (rtPA) in AIS patients who have been on chronic non-vitamin K antagonist oral anticoagulant (DOAC) therapy after receiving a specific reversal agent.

Methods and design

Patients with acute ischemic stroke (AIS) who are treated with specific oral anticoagulants (OACs) with anti-Xa activity have been on chronic non-vitamin K antagonist oral anticoagulant e included in the study. The protocol involves administering a fast-acting antidote (andexanet alfa for rivaroxaban or apixaban) or a placebo, followed by intravenous thrombolytic therapy with rtPA or a placebo. The study arms for rivaroxaban and apixaban are designed as prospective, randomized, placebo-controlled interventional trials that meet phase II trial criteria.

Discussion

The STRoke on Oral AntiCoagulants for Thrombolysis (STROACT) trial is, to our knowledge, the first randomized phase II study designed to explore the feasibility, efficacy, and safety of reversal-enabled intravenous thrombolysis in a highly selected population of acute ischemic stroke patients on factor Xa inhibitors. The results are expected to be hypothesis-generating and may inform the design of future confirmatory trials.

Trial registration

www.clinicaltrialsregister.eu; EudraCT Nr: 2020–004898–41; March 31, 2021.