At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tenecteplase and Alteplase (drug)
- How long the study runs
- Study runs about 35 months (dates as stated)
- About the drug or intervention
- Tenecteplase and Alteplase — drug: The timepoints, dose, and type of IVT will be collected as well as any complications occuring.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at people who have an ischaemic stroke (a stroke caused by a blocked blood vessel in the brain) and who have recently taken a type of blood-thinning medicine called a direct oral anticoagulant (DOAC). The researchers want to learn about the use of intravenous thrombolysis (IVT) — a clot-busting drug given through a drip into a vein — in these patients. The study is run by Insel Gruppe AG, University Hospital Bern.
Who can take part
- Adults diagnosed with an acute ischaemic stroke where guidelines say a clot-busting drug (IVT) may be suitable
- Symptoms started (or the person was last known well) less than 12 hours ago
- A stroke severity score (NIHSS) of 2 points or more on admission
- The person took a direct oral anticoagulant (DOAC) within 48 hours before the clot-busting drug would be given, OR has an ongoing DOAC prescription but the exact time of the last dose cannot be confirmed in an emergency, OR has a DOAC prescription (any dose in the last 7 days) and is receiving the clot-busting treatment
- Informed consent, where this is needed by law and can be obtained
Who may not be able to
- The person refused the use of their biological data for research (Switzerland)
- Any bleeding in or around the brain found on a CT or MRI scan at admission
- Any other absolute reason recorded in the medical record why the clot-busting drug must not be given
- Significant disability before the stroke (a modified Rankin Scale score of 5), including known advanced dementia
- Known serious allergy to Alteplase or Tenecteplase or any of their ingredients
- Women who are pregnant or breastfeeding
What taking part involves
- • Not stated — ask the trial team. The study observes patients who may receive intravenous thrombolysis (a clot-busting drug given through a vein), but details of what the study itself involves are not provided.
Time commitment: Not stated — ask the trial team about number of visits, how long participation lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 2,800
- Started
- 2024-01-01
- Last checked
- 2024-08
Plain English Summary
What is this study?
- • Testing a new treatment for ischemic stroke
- • Clinical study - 2,800 participants
- • DO-IT is an international, prospective observational registry evaluating whether the administration of intravenous thrombolysis (IVT) is safe and improves functional outcome in ischemic stroke patients with recent direct oral anticoagulant (DOAC) intake
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ischemic stroke
Where?
- • London - Imperial College London NHS Trust
- • London - King'S College Hospital Nhs Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
DO-IT is an international, prospective observational registry evaluating whether the administration of intravenous thrombolysis (IVT) is safe and improves functional outcome in ischemic stroke patients with recent direct oral anticoagulant (DOAC) intake. For this purpose, information on 2800 adult participants experiencing an acute ischemic stroke will be obtained at several high-volume international stroke centers and divided into three groups: IVT with recent DOACs intake (DOAC+IVT), and recent DOAC intake not receiving IVT (DOAC) as well as anonymized patients without DOAC receiving IVT. The patients are followed up for 90 days after the index event. treatment recommendations from the described observations. The investigators hypothesize that also more liberal decisions for IVT in patients with recent DOAC intake are not associated with an increased risk for symptomatic intracerebral hemorrhage (sICH) and result in better functional outcome at 3 month.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Clinical diagnosis of acute ischemic stroke with indication for IVT according to applicable guidelines
- ✓Time from symptom onset or last known well \<12 hours
- ✓Admission NIHSS of 2 points or more
- ✓agreement to take part (if obtainable and in those international sites where this is legally required) for the prospective...
Who cannot take part
- ✗Patient refused the use of biological data for research purposes (Switzerland)
- ✗Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan
- ✗Documentation of any other absolute contraindications to IVT in the medical record
- ✗Significant pre-stroke disability (mRS score of 5), including known advanced dementia
- ✗Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
See the full criteria
Where Is This Study? (2 UK sites)
Imperial College London NHS Trust
London, United Kingdom
King'S College Hospital Nhs Foundation Trust
London, United Kingdom
How to Get in Touch
Thomas Meinel, MD, PhD
Sponsor contactCONTACT
Freschta Zipser-Mohammadzada, PhD
Sponsor contactCONTACT