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Safety and Efficacy of Intravenous Thrombolysis in Patients with Ischemic Stroke on Treatment with Direct Oral Anticoagulants: DO-IT – The DOAC Intravenous Thrombolysis trial
EU CTIS ID: 2024-515561-34-01
What this study is testing
The DO-IT trial is a definitive test of the hypothesis that the strategy of IVT (with either alteplase or tenecteplase) is superior to standard of care for achieving better outcome (functional outcome quantified by a shift on the modified Rankin Scale, mRS) at 90 days in AIS patients with recent DOAC ingestion who are otherwise eligible for IVT according to local standards of care.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 o Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR o 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).
You likely can't join if
- 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 o Age > 55 years OR o Age < 55 years and at least 12 months since last menstrual period OR o 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, we 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- Switzerland
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; Switzerland; Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.