Actively Recruiting
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-03-30
906
Participants Needed
14
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent or deferred consent as allowed by local laws
- Have an acute ischemic stroke eligible for intravenous alteplase or tenecteplase treatment
- Have taken direct oral anticoagulants within 48 hours before enrollment or have an ongoing DOAC prescription with unknown last intake time
- Be able to start treatment within 4 hours 15 minutes to 4 hours 30 minutes of last known well time OR have MRI evidence of an acute ischemic lesion less than 4.5 hours old and start treatment within 4.5 hours of symptom recognition
You will not qualify if you...
- Have contraindications to intravenous thrombolysis except recent DOAC intake
- Plan to receive reversal agents for anticoagulation
- Are pregnant or breastfeeding, or women of childbearing potential unless over 55 years old, or younger than 55 but at least 12 months post last menstrual period, or surgically sterilized
- Are younger than 18 years old
- Planned to receive mechanical thrombectomy if the trial already includes 20% of such patients
- Intended treatment with endovascular reperfusion procedures
AI-Screening
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Trial Site Locations
Total: 14 locations
1
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
2
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Not Yet Recruiting
3
GHU Paris Psychiatrie et Neurosciences, Sainte Anne
Paris, France, 75014
Not Yet Recruiting
4
Heidelberg University Hospital
Heidelberg, Germany, 69120
Not Yet Recruiting
5
"Attikon" University Hospital
Athens, Greece, 12462
Not Yet Recruiting
6
National Cerebral and Cardiovascular Center Osaka
Osaka, Kansai, Japan, 565-8565
Not Yet Recruiting
7
Academic Medical Center Amsterdam, Department of Neurology
Amsterdam, Netherlands, 1105
Not Yet Recruiting
8
Canterbury District Health Board
Christchurch, New Zealand, 8011
Not Yet Recruiting
9
Akershus Hospital
Oslo, Norway
Not Yet Recruiting
10
Lisbon Central University Hospital Centre
Lisbon, Portugal, 1150-199
Not Yet Recruiting
11
Vall d'Hebron Stroke Center
Barcelona, Spain, 08035
Not Yet Recruiting
12
University Hospital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
13
Inselspital Bern
Bern, Switzerland, 3010
Actively Recruiting
14
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
Research Team
T
Thomas Meinel, MD, PhD
CONTACT
F
Freschta Zipser-Mohammadzada, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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