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Research

Photo for AVERROES OL Extension LTOLE

AVERROES OL Extension LTOLE

Official Title

Long Term Open Label Extension of the AVERROES trial.

Status

Ongoing

Overview

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.

Study Design

Extention study for follow-up of AVERROES patients

Primary Endpoint

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

Number of Patients

3280

Number of Sites

418

Number of Countries

36

Study Period

2010–2015

Principal Investigator

Stuart Connolly, John Eikelboom

Program Manager

Ellison Themeles, Alina Dragomir

Research Coordinator

Gayle Lewis, Heather Beresh