Actively Recruiting
Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-08-16
2800
Participants Needed
33
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
S
Swiss Stroke Trialist Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of acute ischemic stroke with indication for intravenous thrombolysis (IVT) according to guidelines
- Stroke symptom onset or last known well time less than 12 hours
- Admission NIH Stroke Scale score of 2 points or more
- Recent direct oral anticoagulant (DOAC) use within 48 hours before IVT or ongoing DOAC prescription with unknown last intake time, regardless of IVT treatment, or DOAC intake within 7 days and receiving IVT
- Informed consent obtained where legally required
You will not qualify if you...
- Patient refused use of biological data for research (Switzerland)
- Any acute or subacute intracranial hemorrhage seen on admission brain CT or MRI
- Any other documented absolute contraindications to IVT
- Significant pre-stroke disability (modified Rankin Scale score of 5), including advanced dementia
- Known serious allergy to Alteplase, Tenecteplase, or excipients
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Medical University of Innsbruck
Innsbruck, Austria
Not Yet Recruiting
2
Cliniques Universitaires Saint Luc
Brussels, Belgium
Not Yet Recruiting
3
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
4
The University of British Columbia | Vancouver General Hospital
Vancouver, Canada
Not Yet Recruiting
5
CHU Caen
Caen, France
Not Yet Recruiting
6
Nordwest-Krankenhaus Sanderbusch
Sanderbusch, Germany
Not Yet Recruiting
7
Universitäsklinikum Tübingen
Tübingen, Germany
Not Yet Recruiting
8
Dept. of Medicine, University of Thessaly
Larissa, Thessaly, Greece, 41110
Actively Recruiting
9
A.O.R.N. Antonio Cardarelli Hospital
Naples, Italy
Not Yet Recruiting
10
Ospedali Riuniti Hospital
Palermo, Italy
Not Yet Recruiting
11
Ospedale "Bufalini", Cesena
Perugia, Italy
Actively Recruiting
12
AUSL-IRCCS di Reggio Emilia
Reggio Emilia, Italy
Not Yet Recruiting
13
Akershus Hospital
Oslo, Norway
Not Yet Recruiting
14
Hospital de Egas Moniz
Lisbon, Portugal
Not Yet Recruiting
15
Clinical Centre of Serbia, University Hospital Belgrade
Belgrade, Serbia
Actively Recruiting
16
National University Hospital
Singapore, Singapore, 119228
Actively Recruiting
17
Ljubljana University Medical Centre
Ljubljana, Slovenia
Actively Recruiting
18
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
19
Hospital Universitari de Bellvitge
Barcelona, Spain
Not Yet Recruiting
20
Kantonsspital Aarau
Aarau, Switzerland
Actively Recruiting
21
Unispital Basel
Basel, Switzerland
Actively Recruiting
22
Inselspital Bern, University Hospital Bern
Bern, Switzerland
Actively Recruiting
23
HFR Fribourg
Fribourg, Switzerland
Actively Recruiting
24
University Hospital Geneva
Geneva, Switzerland
Actively Recruiting
25
CHUV Lausanne
Lausanne, Switzerland
Actively Recruiting
26
Kantonsspital Lucerne
Lucerne, Switzerland
Actively Recruiting
27
EOC Lugano
Lugano, Switzerland
Actively Recruiting
28
Hôpital Neuchâtelois
Neuchâtel, Switzerland
Actively Recruiting
29
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
30
Hirslanden Zurich
Zurich, Switzerland
Actively Recruiting
31
University Hospital Zurich
Zurich, Switzerland
Actively Recruiting
32
Imperial College London NHS Trust
London, United Kingdom
Not Yet Recruiting
33
King'S College Hospital Nhs Foundation Trust
London, United Kingdom
Not Yet Recruiting
Research Team
T
Thomas Meinel, MD, PhD
CONTACT
F
Freschta Zipser-Mohammadzada, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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