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 Type
OBSERVATIONAL
Enrollment
2,800
The timepoints, dose, and type of IVT will be collected as well as any complications occuring.
Medical University of Innsbruck
Innsbruck, Austria
NOT_YET_RECRUITINGCliniques Universitaires Saint Luc
Brussels, Belgium
NOT_YET_RECRUITINGUZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGThe University of British Columbia | Vancouver General Hospital
Vancouver, Canada
NOT_YET_RECRUITINGNumber of Participants with symptomatic intracerebral hemorrhage (sICH)
Defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage.
Time frame: Within 36 hours after IVT
Dichotomized good functional outcome (mRS 0-2)
Modified Rankin Scale from 0 (no disability) to 6 (death)
Time frame: At day 90 or return to baseline (+/- 2 weeks) after admission
Rate of IVT among IVT-eligible DOAC patients
To determine the rate of IVT in eligible patients with acute ischemic stroke and recent DOAC intake.
Time frame: Through study completion, an average of 2 years
All-cause mortality, major bleeding and orolingual edema
Time frame: From date of randomization until the date of all-cause mortality, major bleeding or orolingual edema, whichever came first, assessed up to 7 days.
Categorical shift in the modified Rankin Scale (mRS)
Modified Rankin Scale from 0 (no disability) to 6 (death)
Time frame: At Day 90 (+/-2 weeks) after admission
Stroke severity (NIHSS)
National Institutes of Health Stroke Scale from 0 (no symptoms) to 39 (most severe symptoms)
Time frame: At 24 hours ±8 hours
Ischemic stroke volume at 24 hours (mL)
Time frame: At 24 hours ±8 hours
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CHU Caen
Caen, France
NOT_YET_RECRUITINGNordwest-Krankenhaus Sanderbusch
Sanderbusch, Germany
NOT_YET_RECRUITINGUniversitäsklinikum Tübingen
Tübingen, Germany
NOT_YET_RECRUITINGDept. of Medicine, University of Thessaly
Larissa, Thessaly, Greece
RECRUITINGA.O.R.N. Antonio Cardarelli Hospital
Naples, Italy
NOT_YET_RECRUITINGOspedali Riuniti Hospital
Palermo, Italy
NOT_YET_RECRUITING...and 23 more locations