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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,800
- Locations
- 33
- Primary Endpoint
- Dichotomized good functional outcome (mRS 0-2)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
DOAC+IVT
Acute ischemic Stroke patients with recent DOACs intake receive IVT.
Intervention: Tenecteplase and Alteplase (Drug)
Outcomes
Primary Outcomes
Dichotomized good functional outcome (mRS 0-2)
Time Frame: At day 90 or return to baseline (+/- 2 weeks) after admission
Modified Rankin Scale from 0 (no disability) to 6 (death)
Number of Participants with symptomatic intracerebral hemorrhage (sICH)
Time Frame: 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.
Secondary Outcomes
- Rate of IVT among IVT-eligible DOAC patients(Through study completion, an average of 2 years)
- Categorical shift in the modified Rankin Scale (mRS)(At Day 90 (+/-2 weeks) after admission)
- 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.)
- Stroke severity (NIHSS)(At 24 hours ±8 hours)
- Ischemic stroke volume at 24 hours (mL)(At 24 hours ±8 hours)