What is the clinical evidence from this study?

Study design: RCT. Population: acute ischemic stroke (AIS) (n=906). Intervention: Intravenous thrombolysis (IVT) vs. best medical therapy. Primary outcome: 90-days (±2 weeks) functional status on the modified Rankin Scale using a shift analysis.

What question did this study set out to answer?

The trial aims to assess the safety and efficacy of intravenous thrombolysis in ischemic stroke patients treated with direct oral anticoagulants.

May 8, 2026Open Access

Abstract Number: Esoc2026ot8 Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: Do-It – The Doac Intravenous Thrombolysis Trial (Do-It)

Key Result

The DO-IT trial is an ongoing international, multicenter RCT randomizing 906 patients with acute ischemic stroke and recent DOAC use to intravenous thrombolysis or best medical therapy.

Key Points

The trial aims to assess the safety and efficacy of intravenous thrombolysis in ischemic stroke patients treated with direct oral anticoagulants.
Multicenter trial randomizing 906 patients to intravenous thrombolysis or best medical therapy.
Inclusion criteria focused on recent use of direct oral anticoagulants and disabling ischemic stroke.
Primary outcomes measured were functional status at 90 days and incidence of symptomatic intracranial hemorrhage.
The efficacy outcome evaluates functional status using the modified Rankin Scale at 90 days.
The safety outcome defines symptomatic intracranial hemorrhage based on ECASS-2 criteria.
Results will indicate the effectiveness of intravenous thrombolysis in a previously contraindicated patient population.

Study Design

Type

RCT (n=906)

Randomization

1:1

Multicenter

Yes

Structured PICO

Does intravenous thrombolysis improve functional status and maintain safety in patients with acute ischemic stroke on recent DOAC treatment?

Population

906 patients with disabling acute ischemic stroke (AIS) within the thrombolysis window (randomization ≤4 h 15 min; treatment ≤ 4 h 30 min) who have taken a direct oral anticoagulant (DOAC) within the past 48 hours or unknown time.

Intervention

Intravenous thrombolysis (IVT)

Comparator

Best medical therapy

Outcome

90-days (±2 weeks) functional status on the modified Rankin Scale using a shift analysis (efficacy) and symptomatic intracranial hemorrhage (ECASS-2 definition) (safety)hard clinical

The DO-IT trial will provide randomized evidence on the safety and efficacy of intravenous thrombolysis for acute ischemic stroke in patients with recent DOAC use, a practice currently advised against by guidelines.

Abstract

Abstract Background and aims Intravenous thrombolysis (IVT) effectively reduces disability in acute ischemic stroke (AIS), with a number needed to treat of 10 when given early. Yet, recent direct oral anticoagulant (DOAC) use—affecting ~20% of eligible patients—is the most common reason IVT is withheld. Methods Guidelines currently advise against IVT after recent DOAC use, despite limited evidence supporting this caution. Preclinical and observational data have not shown increased intracranial bleeding with off-label IVT, and no randomized trial has assessed its safety or efficacy in this setting. This trial aims to evaluate the safety and effectiveness of IVT in patients with AIS who have taken a DOAC within the past 48 hours. Results DO-IT is an international, multicenter trial randomizing 906 patients (1:1) to IVT or best medical therapy. Main inclusion criteria are DOAC use (≤ 48 h or unknown) and disabling AIS within the thrombolysis window (randomization ≤4 h 15 min; treatment ≤ 4 h 30 min). Exclusions include standard IVT contraindications and prior DOAC reversal. Conclusions The primary efficacy outcome is 90-days (±2 weeks) functional status on the modified Rankin Scale using a shift analysis. The primary safety outcome is symptomatic intracranial hemorrhage (ECASS-2 definition). Conflict of interest