Status:
RECRUITING
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 partic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
906 Patients enrolled
Trial Details
Trial ID
NCT06571149
Start Date
March 14 2025
End Date
April 30 2029
Last Update
March 30 2025
Active Locations (14)
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1
UZ Leuven
Leuven, Belgium, 3000
2
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
3
GHU Paris Psychiatrie et Neurosciences, Sainte Anne
Paris, France, 75014
4
Heidelberg University Hospital
Heidelberg, Germany, 69120