Ischemic Stroke
Conditions
Keywords
DOAC (Direct Oral AntiCoagulants), NOAC (Novel Oral AntiCoagulants), Anticoagulation, r-tPA (tissue-type plasminogen activator), Alteplase, Tenecteplase, Rivaroxaban, Apixaban, Dabigatran, Edoxaban
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.
Interventions
DRUGTenecteplase and Alteplase
The timepoints, dose, and type of IVT will be collected as well as any complications occuring.
Sponsors
Swiss Stroke Trialist Association
Swiss Stroke Registry
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with symptomatic intracerebral hemorrhage (sICH) | Within 36 hours after IVT | Defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage. |
| Dichotomized good functional outcome (mRS 0-2) | At day 90 or return to baseline (+/- 2 weeks) after admission | Modified Rankin Scale from 0 (no disability) to 6 (death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Categorical shift in the modified Rankin Scale (mRS) | At Day 90 (+/-2 weeks) after admission | Modified Rankin Scale from 0 (no disability) to 6 (death) |
| Rate of IVT among IVT-eligible DOAC patients | Through study completion, an average of 2 years | To determine the rate of IVT in eligible patients with acute ischemic stroke and recent DOAC intake. |
| Ischemic stroke volume at 24 hours (mL) | At 24 hours ±8 hours | — |
| Stroke severity (NIHSS) | At 24 hours ±8 hours | National Institutes of Health Stroke Scale from 0 (no symptoms) to 39 (most severe symptoms) |
| All-cause mortality, major bleeding and orolingual edema | From date of randomization until the date of all-cause mortality, major bleeding or orolingual edema, whichever came first, assessed up to 7 days. | — |
Countries
Austria, Belgium, Canada, France, Germany, Greece, Italy, Norway, Portugal, Serbia, Singapore, Slovenia, Spain, Switzerland, United Kingdom
Contacts
Primary ContactThomas Meinel, MD, PhD
Backup ContactFreschta Zipser-Mohammadzada, PhD
Outcome results
None listed