CTU Bern

ELAN trial shows: early initiation of treatment with blood thinners after stroke is safe and possibly more effective

26.05.2023 – About 80% of all strokes are caused by blockage of an artery in the brain (ischemia). Of these, up to 20% are caused by blood clots that form in the heart in people with atrial fibrillation. Blood thinners called direct oral anticoagulants (DOACs) are used to prevent blood clots in people with atrial fibrillation.

To date, it is unclear how early after a stroke this treatment should be started. There may be an increased risk of bleeding, which may be highest in the first few days after the stroke. On the other hand, the potential benefit of these drugs may also be greatest in the first few days. Given these uncertainties, international guidelines currently recommend delaying the start of DOAC treatment. The ELAN addressed this open question by comparing the timing of initiation of direct oral anticoagulants ischemic stroke patients with atrial fibrillation. A total of 2013 patients were enrolled in more than 100 sites in 13 countries worldwide. 1006 patients were randomly assigned to an early initiation group while 1007 were assigned to the late group. The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, and vascular death measured at 30 days follow-up. A total of 29 (2.9%) patients experienced at least one event composing the primary outcome at 30 days in the early group, while the number of patients was 41 (4.1%) in the late group. The estimated Odds Ratio was 0.70 (95%-CI, 0.44 to 1.14) and the corresponding risk difference was -1.18% (95%-CI, -2.84 to 0.47%) in favor of the early group. 

CTU Bern was heavily involved from the planning until the publication of the trial supporting the trial database (Data Management), the quality of the data (Central Data Monitoring) and the full statistical analysis process (Statistics and Methodology).

Please find the publication here: https://www.nejm.org/doi/full/10.1056/NEJMoa2303048?query=featured_home