Clot-busting drugs in stroke patients recently taking blood thinners
Observes ischemic stroke patients who recently took blood thinners and received clot-busting treatment.
Plain-language title generated from the registry record
Registry title: Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
Key facts
- Where
- Ljubljana, SloveniaSee the site
Where in Slovenia
- Ljubljana University Medical CentreLjubljana, SloveniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT06556446
- Record updated
- 16 August 2024
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants: the DOAC - International Thrombolysis (DO-IT) Cohort Study
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.
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: Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan; Significant pre-stroke disability (mRS score of 5), including known advanced dementia; Patient refused the use of biological data for research purposes (Switzerland); Documentation of any other absolute contraindications to IVT in the medical record; Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients; Pregnancy or lactating women.