Evaluating thrombolysis safety in stroke patients who recently took 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

This study is testing if giving a clot-busting treatment to stroke patients who recently took blood thinners is safe and helps them recover better.

Quick facts

• Study type: Observational
• Enrollment: 2800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 33 sites (Innsbruck and 32 other locations)
• Trial ID: NCT06556446 on ClinicalTrials.gov

What this trial studies

This international observational registry aims to assess the safety and effectiveness of intravenous thrombolysis (IVT) in patients with acute ischemic stroke who have recently ingested direct oral anticoagulants (DOACs). The study will involve 2800 adult participants from high-volume stroke centers, divided into three groups: those receiving IVT after DOAC intake, those with DOAC intake not receiving IVT, and a control group without DOACs receiving IVT. Participants will be followed for 90 days post-event to evaluate functional outcomes and the risk of symptomatic intracerebral hemorrhage. The hypothesis is that more liberal use of IVT in these patients may not increase the risk of complications and could improve recovery outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with acute ischemic stroke who have taken DOACs within the last 48 hours and meet the criteria for IVT.

Not a fit: Patients with acute or subacute intracranial hemorrhage or those with absolute contraindications to IVT will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer treatment protocols for stroke patients on anticoagulants, improving their recovery chances.

How similar studies have performed: While the approach is novel, previous studies have explored thrombolysis in anticoagulated patients, but this specific focus on DOACs is less common.

Eligibility criteria

Inclusion Criteria:

1. Clinical diagnosis of acute ischemic stroke with indication for IVT according to applicable guidelines
2. Time from symptom onset or last known well \<12 hours
3. Admission NIHSS of 2 points or more
4. 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
5. Informed consent (if obtainable and in those international sites where this is legally required) for the prospective part

Exclusion Criteria:

1. Patient refused the use of biological data for research purposes (Switzerland)
2. Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan
3. Documentation of any other absolute contraindications to IVT in the medical record
4. Significant pre-stroke disability (mRS score of 5), including known advanced dementia
5. Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
6. Pregnancy or lactating women.

Where this trial is running

Innsbruck and 32 other locations

• Medical University of Innsbruck — Innsbruck, Austria (Not_yet_recruiting)
• Cliniques Universitaires Saint Luc — Brussels, Belgium (Not_yet_recruiting)
• UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
• The University of British Columbia | Vancouver General Hospital — Vancouver, Canada (Not_yet_recruiting)
• CHU Caen — Caen, France (Not_yet_recruiting)
• Nordwest-Krankenhaus Sanderbusch — Sanderbusch, Germany (Not_yet_recruiting)
• Universitäsklinikum Tübingen — Tübingen, Germany (Not_yet_recruiting)
• Dept. of Medicine, University of Thessaly — Larissa, Thessaly, Greece (Recruiting)
• A.O.R.N. Antonio Cardarelli Hospital — Naples, Italy (Not_yet_recruiting)
• Ospedali Riuniti Hospital — Palermo, Italy (Not_yet_recruiting)
• Ospedale "Bufalini", Cesena — Perugia, Italy (Recruiting)
• AUSL-IRCCS di Reggio Emilia — Reggio Emilia, Italy (Not_yet_recruiting)
• Akershus Hospital — Oslo, Norway (Not_yet_recruiting)
• Hospital de Egas Moniz — Lisbon, Portugal (Not_yet_recruiting)
• Clinical Centre of Serbia, University Hospital Belgrade — Belgrade, Serbia (Recruiting)
• National University Hospital — Singapore, Singapore (Recruiting)
• Ljubljana University Medical Centre — Ljubljana, Slovenia (Recruiting)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
• Hospital Universitari de Bellvitge — Barcelona, Spain (Not_yet_recruiting)
• Kantonsspital Aarau — Aarau, Switzerland (Recruiting)
• Unispital Basel — Basel, Switzerland (Recruiting)
• Inselspital Bern, University Hospital Bern — Bern, Switzerland (Recruiting)
• HFR Fribourg — Fribourg, Switzerland (Recruiting)
• University Hospital Geneva — Geneva, Switzerland (Recruiting)
• CHUV Lausanne — Lausanne, Switzerland (Recruiting)
• Kantonsspital Lucerne — Lucerne, Switzerland (Recruiting)
• EOC Lugano — Lugano, Switzerland (Recruiting)
• Hôpital Neuchâtelois — Neuchâtel, Switzerland (Recruiting)
• Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
• Hirslanden Zurich — Zurich, Switzerland (Recruiting)
• University Hospital Zurich — Zurich, Switzerland (Recruiting)
• Imperial College London NHS Trust — London, United Kingdom (Not_yet_recruiting)
• King'S College Hospital Nhs Foundation Trust — London, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: Thomas Meinel, MD, PhD

Conditions Ischemic Stroke; DOAC; NOAC; Anticoagulation; r-tPA; Alteplase; Tenecteplase; Rivaroxaban