Long Term Open Label Extension of the AVERROES trial.
Following the recommendation of the Data Safety and Monitoring Committee of the AVERROES trial to terminate the study early because of a clear benefit in favour of apixaban, an LTOLE study was implemented 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 ethic committees prior to implementation. 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