Long Term Open Label Extension of the AVERROES trial.
To provide ongoing open-label apixaban therapy to participants of the AVERROES trial until apixaban was approved and commercially available in their respective countries. Participation in LTOLE was optional for all sites/participants and required separate participant informed consent and approval from health authorities and local ethics committees. Follow-up visits occur at 1 month and every 6 months after enrollment into LTOLE and continue until the participant withdraws or the decision is made to end the LTOLE study at a given country/site due to availability of commercial apixaban or suitable alternative. Outcome and safety assessments are performed in a similar fashion as in AVERROES follow-up visits.
Extention study for follow-up of AVERROES patients
Participant safety is monitored and reported regularly, however there is no ‘endpoint’
Stuart Connolly, John Eikelboom
Ellison Themeles, Alina Dragomir
Gayle Lewis, Heather Beresh