#ANNEXa_4 - Twitter Hashtag

over 2 years ago

5d) As #ANNEXa_4 (🔓https://t.co/T8UrNqqfgY), the trial that ➡️ authorization, was an open-label, single-cohort (#andexanet) study, a randomized study was needed to further explore its safety & efficacy. As there is no other approved tx, comparison was made to "usual care."

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@cardiomet_CE

over 2 years ago

5d) As #ANNEXa_4 (🔓https://t.co/T8UrNqqfgY), the trial that ➡️ authorization, was an open-label, single-cohort (#andexanet) study, a randomized study was needed to further explore its safety & efficacy. As there is no other approved tx, comparison was made to "usual care."

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@cardiomet_CE

almost 3 years ago

25) Similar findings from studies comparing #ANNEXa_4 patients to synthetic control arms have been published. Here’s one from @StrokeAHA_ASA. One caveat is that ANNEXa-4 excluded patients with low #GCS scores and high hematoma volumes. 🔓https://t.co/u3u5b89E0w

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@cardiomet_CE

almost 3 years ago

12) Andexanet was provisionally approved by @US_FDA based on a series of open-label cohort studies such as #ANNEXa_4 (🔓 https://t.co/4MlyxDqYi9). Endpoint driven dually by measured anti-#FXa activity and clinical + radiographic measures of #hemostasis.

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@cardiomet_CE

over 3 years ago

26a) While assessing anti-FXa activity calibrated for rivaroxaban or apixaban may help, the time of last dose taken is sufficient to guide dosing, as #ANNEXA_4 did not mandate #aFXa activity for #Andexanet administration.

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@cardiomet_CE

over 3 years ago

9) Truth be told, there are no data from high-quality large RCTs with direct comparison of #Andexanet with 4 factor #PCC in the context of #ICH…! The largest trial to date is the open label #ANNEXA_4 trial (🔓https://t.co/XFI4Zxhata the post-hoc analyses that followed.

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@cardiomet_CE

almost 4 years ago

8) In fact, high mortality rates are seen after specific anticoagulant #reversal for major #GI bleeding in patients taking #dabigatran (idarucizumab in the #REVERSE_AD study) and factor Xa inhibitors (#andexanet_alfa in the #ANNEXA_4 study).

cardiomet_CE's tweet photo. 8) In fact, high mortality rates are seen after specific anticoagulant #reversal for major #GI bleeding in patients taking #dabigatran (idarucizumab in the #REVERSE_AD study) and factor Xa inhibitors (#andexanet_alfa in the #ANNEXA_4 study). https://t.co/tNuyiOPfAc

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@cardiomet_CE

almost 4 years ago

9) We focus here in the questions asked of the panel at the live symposium . . . starting with "The #ANNEXA_4 study [🔓https://t.co/8YZ1dGWyAp] was an open-label study of #andexanet for reversal of #DOACs. Why was there no control group and how do we know it really worked?"

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World Stroke Academy @WorldStrokeEd

about 5 years ago

#WeekendLecture #ESOC2021 #ANNEXA_4 #Andexanet alfa is an inactive FXa form that can reverse FXa inhibitors 479pts with major bleeding Good/excellent hemostasis was achieved in 80% Correlation between lower antiFXa and: Mortality in <75yo pts Hemostatic efficacy in #ICH group