Thrombolysis for stroke patients on Factor Xa inhibitors

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 trial investigates the safety and effectiveness of intravenous thrombolysis (IVT) in patients with acute ischemic stroke (AIS) who have taken Factor Xa inhibitors within the last 48 hours. It aims to challenge current guidelines that prohibit IVT for these patients due to concerns about bleeding risks. The study will compare outcomes between two groups: one receiving IVT and the other receiving standard care without IVT. By utilizing a pragmatic, multicenter approach, the trial seeks to provide robust evidence on the potential benefits of IVT in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant must be 18 years of age or older.
2. Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)
3. Clinical diagnosis of AIS with disabling neurological deficit
4. Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist.
5. Informed consent

Exclusion Criteria:

1. Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography and expected time from randomization to groin puncture of \<30 minutes.
2. Systolic BP \>185 mmHg or diastolic BP \>110 mmHg despite antihypertensive treatment.
3. Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.
4. Arterial puncture at a non-compressible site; biopsy or lumbar puncture \<7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma \<14 days; history of intracranial haemorrhage; stroke \<2 months, CNS neurosurgery \<2 months; serious head trauma \<2 months; pericarditis; sepsis; bacterial endocarditis; pericarditis; acute pancreatitis; neoplasm with increased bleeding risk; any serious medical illness likely to interact with treatment (i.e. aortic dissection); confounding pre-existent neurological or psychiatric disease.
5. Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia greater than one-third of the middle cerebral artery territory).

   Prior/Concomitant Therapy
6. Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \<48 h; d) treatment dose of LMWH \<24 h.

   Prior/Concurrent Clinical Study Experience
7. Hypersensitivity to Alteplase or Tenecteplase

Where it's running

• Dept. of Neurology, Aalborg Universitetshospital
  Aalborg, Aalborg, Denmark Recruiting
• Dept of Neurology Aarhus University Hospital
  Aarhus, Aarhus N, Denmark Recruiting
• Dept. of Medicine, Baerum Hospital
  Baerum, Gjettum, Norway Recruiting
• Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital
  Ålesund, Norway Recruiting
• Dept of Medicine, Haraldsplass deaconal Hospital
  Bergen, Norway Recruiting
• Dept. Of Neurology, Haukeland University Hopsital
  Bergen, Norway Recruiting

Study contacts

• Principal investigator: Håkon Ihle-Hansen, MD, PhD — Dept. of Medicine, Baerum Hospital
• Study coordinator: Guri Hagberg, MD, PhD
• Email: guhagb@ous-hf.no
• Phone: +47 92821843

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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.