Status:
RECRUITING
Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Swiss Stroke Trialist Association
Swiss Stroke Registry
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
- Informed consent (if obtainable and in those international sites where this is legally required) for the prospective part
Exclusion
- 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
- Pregnancy or lactating women.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
2800 Patients enrolled
Trial Details
Trial ID
NCT06556446
Start Date
January 1 2024
End Date
December 31 2026
Last Update
August 16 2024
Active Locations (33)
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1
Medical University of Innsbruck
Innsbruck, Austria
2
Cliniques Universitaires Saint Luc
Brussels, Belgium
3
UZ Leuven
Leuven, Belgium, 3000
4
The University of British Columbia | Vancouver General Hospital
Vancouver, Canada