The objective of the AVERROES LTOLE study was 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 of the AVERROES study, and required separate participant informed consent and approval from health authorities and local ethics committees.

Follow-up visits occurred at 1 month and every 6 months after enrollment into LTOLE, and continued until the participant withdrew or the decision was 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.

Participant safety was monitored and reported regularly, however there was no ‘endpoint.’

Study Type

Interventional - Drug

Study Design

Open-label extension

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2010 - 2017


Bristol-Myers Squibb

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