Evaluating the safety and effectiveness of thrombolysis in stroke patients on blood thinners

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, multicenter trial investigates the safety and efficacy of intravenous thrombolysis (IVT) in adults who have experienced an acute ischemic stroke (AIS) and have taken direct oral anticoagulants (DOAC) within the last 48 hours. Participants will be randomly assigned to receive either IVT combined with standard care or standard care alone. The study aims to determine if IVT leads to better outcomes at 90 days compared to standard treatment in this specific patient population. A total of 906 participants will be enrolled across several high-volume stroke centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed consent (deferred consent when possible according to national legislation)
* AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician
* DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown.
* Either

  * Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR
  * MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening).

Exclusion Criteria:

* Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above.
* Intended reversal by specific or unspecific reversal agents
* Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria

  * Age \> 55 years OR
  * Age \< 55 years and at least 12 months since last menstrual period OR
  * Have had a documented surgical sterilization
* Patient \< 18 years of age (since the benefit of IVT is unproven in this population)

Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied:

* Intended treatment with endovascular reperfusion strategies

Where it's running

• Barmherzige Brüder Krankenhaus Eisenstadt
  Eisenstadt, Austria Recruiting
• Universitätsklinik für Neurologie Graz
  Graz, Austria Recruiting
• Christian Doppler Klinik
  Salzburg, Austria Recruiting
• Barmherzige Brüder Krankenhaus Wien
  Vienna, Austria Recruiting
• Medizinische Universität Wien
  Vienna, Austria Recruiting
• AZ Sint-Jan Brugge AV
  Bruges, Belgium Recruiting

+59 more sites. See ClinicalTrials.gov for the full list.

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.