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AVERROES - LTOLE

Official Title

Long Term Open Label Extension of the AVERROES trial.

Status

Completed

Overview

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

Number of Patients

3280

Number of Sites

419

Number of Countries

36

Study Period

2010–2018

Principal Investigator

Stuart Connolly

Program Manager

Heather Beresh (previously Ellison Themeles)

Research Coordinator

Sandra Nevills (previously Gayle Lewis)

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