NCT06556446 Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
| NCT ID | NCT06556446 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,800 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,800 participants in total. It began in 2024-01-01 with a primary completion date of 2026-03-31.
⚠ 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, 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.
Eligibility Criteria
Inclusion Criteria: 1. Clinical diagnosis of acute ischemic stroke with indication for IVT according to applicable guidelines 2. Time from symptom onset or last known well \<12 hours 3. Admission NIHSS of 2 points or more 4. either DOAC ingestion within 48 hours prior to expected timepoint of IVT bolus, or patient with an ongoing prescription of DOAC, but exact timepoint of last intake not verifiable in the emergency setting. (regardless of whether intravenous thrombolysis was given) OR DOAC prescription (any intake within the last 7 days) and receiving intravenous thrombolysis 5. Informed consent (if obtainable and in those international sites where this is legally required) for the prospective part Exclusion Criteria: 1. Patient refused the use of biological data for research purposes (Switzerland) 2. Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan 3. Documentation of any other absolute contraindications to IVT in the medical record 4. Significant pre-stroke disability (mRS score of 5), including known advanced dementia 5. Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients 6. Pregnancy or lactating women.
Contact & Investigator
Thomas Meinel, MD, PhD
STUDY DIRECTOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06556446 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.
Is NCT06556446 currently recruiting?
Yes, NCT06556446 is actively recruiting participants. Contact the research team at thomas.meinel@insel.ch for enrollment information.
Where is the NCT06556446 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Brussels, Belgium, Leuven, Belgium, Vancouver, Canada and 11 additional locations.
Who is sponsoring the NCT06556446 clinical trial?
NCT06556446 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 2,800 participants.
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