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ClinicalTrials.gov ID

NCT06571149

Lead Sponsor

Insel Gruppe AG, University Hospital BernOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

906Estimated

Last Update Posted

Aug 3, 2026Actual

Start Date

Mar 14, 2025Actual

Primary Completion Date

Jan 31, 2029Estimated

Completion Date

Apr 30, 2029Estimated

Official Title

Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: DO-IT - The DOAC Intravenous Thrombolysis Trial

Brief Summary

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.

• Ischemic Stroke

• Tenecteplase or Alteplase

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Informed consent (deferred consent when possible according to national legislation)

• AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician

• DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.

• Either

  • Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
  • MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).

Exclusion Criteria:

• Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.

• Intended reversal by specific or unspecific reversal agents

• Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria

  • Age > 55 years OR
  • Age < 55 years and at least 12 months since last menstrual period OR
  • Have had a documented surgical sterilization

• Patient < 18 years of age (since the benefit of IVT is unproven in this population)

Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:

• Intended treatment with endovascular reperfusion strategies

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Insel Gruppe AG, University Hospital BernOTHER

ayhan.findik@saintluc.uclouvain.be+32 2 764 1080