NCT06571149 Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
| NCT ID | NCT06571149 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 906 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 906 participants in total. It began in 2025-03-14 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Thomas Meinel, MD, PhD
STUDY DIRECTOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06571149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06571149 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06571149 currently recruiting?
Yes, NCT06571149 is actively recruiting participants. Contact the research team at thomas.meinel@insel.ch for enrollment information.
Where is the NCT06571149 trial being conducted?
This trial is being conducted at Eisenstadt, Austria, Graz, Austria, Innsbruck, Austria, Salzburg, Austria and 11 additional locations.
Who is sponsoring the NCT06571149 clinical trial?
NCT06571149 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Thomas Meinel, MD, PhD at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 906 participants.
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