Assessment of our registered patients’ eligibility for Phase III
trials of DOACs
We scrutinised the most frequently used inclusion and exclusion criteria
of the four DOACs Phase III trials (Table 1).1,2,4,5Baseline data collected at registration for all patients (medical
history, background, and laboratory values) were checked against the
developed inclusion and exclusion criteria to assess eligibility.
Regarding the CHADS2 score, two trials used ≥2 as a criterion, and the
others used ≥1. We used ≥2 as our criterion. Therefore, ineligible
patients included those with a CHADS2 score of
<2. In addition, we checked the baseline data against each
Phase III trial’s inclusion and exclusion criteria.