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Tests treatment safety and results for Ischemic Stroke
Official title Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
ClinicalTrials.gov ID: NCT06571149
What this study is testing
What is Tenecteplase or Alteplase?
Tenecteplase or Alteplase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
- Can be assigned by chance within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
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...
- Age \> 55 years OR
- Age \< 55 years and at least 12 months since last menstrual period OR
- Have had a documented surgical sterilization
See the full eligibility 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 assigned by chance 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...
- 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...
- Intended treatment with endovascular reperfusion strategies
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Hamilton, Ontario, Canada
- Paris, France
- Heidelberg, Germany
- Athens, Greece
- Osaka, Kansai, Japan
- Amsterdam, Netherlands
- Christchurch, New Zealand
- Oslo, Norway
- Lisbon, Portugal
- Barcelona, Spain
- Basel, Switzerland
- Bern, Switzerland
- Sankt Gallen, Switzerland
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Hamilton, Ontario, Canada; Paris, France; Heidelberg, Germany; Athens, Greece; Osaka, Kansai, Japan and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.