Evaluating thrombolysis safety in stroke patients who recently took anticoagulants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dept. of Medicine, University of Thessaly
  Larissa, Thessaly, Greece Recruiting
• Ospedale "Bufalini", Cesena
  Perugia, Italy 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

Study contacts

• Study coordinator: Thomas Meinel, MD, PhD
• Email: thomas.meinel@insel.ch
• Phone: +41 31 66 4 25 67

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.