A Phase 4 interventional study of Tenecteplase or Alteplase in Ischemic Stroke, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 109 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 4, Interventional, and Treatment
DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.
2,595 studies on the registry are indexed under Ischemic Stroke; 932 are open to participants now.
This study's planned enrollment of 906 is above the median of 120 across 1,754 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Either
Exclusion Criteria:
Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria
Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:
Patients will receive Standard of care/Best medical treatment according to local applicable guidelines, including the current American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation/ European Society of Minimally Invasive Neurological Therapy (ESO/ESMINT) guidelines.
Patients will receive intravenous administration of Tenecteplase or Alteplase.
Drug: Tenecteplase or Alteplase
Patients randomized to intravenous thrombolysis (IVT) treatment will receive intravenous Tenecteplase or Alteplase.
Modified Rankin Scale (mRS)
Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).
Time frame: 90 days +/- 2 weeks after randomization
Dichotomized modified Rankin Scale (mRS) 0-2 (good functional outcome)
Modified Rankin Scale is a scale that runs from 0-6, running from perfect health without symptoms (0) to death (6).
Time frame: 90 days +/- 2 weeks post-randomization
Change from baseline in stroke severity (National Institutes of Health Stroke Scale, NIHSS)
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Thus, 0 (minimum score) means "no symptoms", whereas 42 (maximum score) means "severe stroke".
Time frame: 24 +/- 12 hours after Intervention
Health-related Quality of Life (EuroQol 5D-3L questionnaire)
The EuroQol 5D-3L (EuroQol 5 Dimensions with each 3 Levels) measures health-related Quality of Life.
Time frame: 90 days +/- 2 weeks post-randomization
Rate of Symptomatic intracranial hemorrhage
Observed in clinical imaging
Time frame: Within the first 36 hours post-randomization
Rate of Major extracranial bleeding
Defined as clinically overt bleeding that is accompanied by one or more of the following (according to International Society on Thrombosis and Haemostasis definitions): * Decrease in haemoglobin of ≥ 2g / dl over a 24-hour period * Transfusion of ≥ 2 units of packed red blood cells * Occurring in a critical part of the body (intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal) * In order for bleeding (e.g. gastrointestinal) in a critical area or organ to be classified as a major extracranial bleeding it must be associated with a symptomatic clinical presentation.
Time frame: Within the first 24 hours post-randomization
All-cause mortality
Death from any cause
Time frame: Up to 7 to 10 days after admission or until discharge, usually 2 weeks after admission
Showing the first 100 of 109 sites across 12 countries.
Plan to share: Yes — IPDMA (individual participant data meta-analysis) of similar interventional clinical studies is planned.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Insel Gruppe AG, University Hospital Bern