NCT06556446Recruiting
Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
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
Source: ClinicalTrials.gov · Last updated 16 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2800 (estimated)
- First submitted
- 24 Jun 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Stroke
- NCT number
- NCT06556446
What you commit to
- Study type: Observational
- Planned participants: 2800
- From 1 Jan 2024 to the primary completion date, 31 Mar 2026
- 33 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan
- Significant pre-stroke disability (mRS score of 5), including known advanced dementia
Other
- Patient refused the use of biological data for research purposes (Switzerland)
- Documentation of any other absolute contraindications to IVT in the medical record
- Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
- Pregnancy or lactating women.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Not yet recruiting |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| The University of British Columbia | Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Not yet recruiting |
| Kantonsspital Aarau Coordinator of this site? Confirm its status | Aarau | Switzerland | Recruiting |
| Unispital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Inselspital Bern University Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| HFR Fribourg Coordinator of this site? Confirm its status | Fribourg | Switzerland | Recruiting |
| University Hospital Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| CHUV Lausanne Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| Kantonsspital Lucerne Coordinator of this site? Confirm its status | Lucerne | Switzerland | Recruiting |
| EOC Lugano Coordinator of this site? Confirm its status | Lugano | Switzerland | Recruiting |
| Hôpital Neuchâtelois Coordinator of this site? Confirm its status | Neuchâtel | Switzerland | Recruiting |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Hirslanden Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Nordwest-Krankenhaus Sanderbusch Coordinator of this site? Confirm its status | Sanderbusch | Germany | Not yet recruiting |
| Universitäsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Not yet recruiting |
| Imperial College London NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Dept. of Medicine, University of Thessaly Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
| A.O.R.N. Antonio Cardarelli Hospital Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Ospedali Riuniti Hospital Coordinator of this site? Confirm its status | Palermo | Italy | Not yet recruiting |
| Ospedale "Bufalini", Cesena Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| AUSL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Not yet recruiting |
| Akershus Hospital: Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
| Hospital de Egas Moniz Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Clinical Centre of Serbia, University Hospital Belgrade Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Ljubljana University Medical Centre Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.