parallel randomized trial

TEXAIS

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

A Multicentre, Randomised Controlled Trial of Exenatide Versus Standard Care in Acute Ischemic Stroke (TEXAIS)

Other conditions NCT03287076S000310

Design

Randomized: 350
Start year: 2016
Treatment: 0.71 weeks, follow-up 12.86 weeks
Countries: Australia, New Zealand, Finland (12 sites)
Sponsor: Neuroscience Trials Australia (non industry)
Eligibility: age 18 or older; acute ischemic stroke within 9 h; glucose 4 mmol/L or more; prestroke mRS 2 or less

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 5 ug subcutaneous twice daily Exenatide plus standard care	standard stroke unit care; antiemetic for first 48 hours; lifestyle: not reported	177	170
A2	Standard care or no added treatment Standard care	standard stroke unit care; lifestyle: not reported	173	171

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Whole trial ALL
age	median (years)	71
age	q1 (years)	62
age	q3 (years)	79

Results

2 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	3.5			6 /	not stated; modified itt; nausea/vomiting; R0007546:Results
	A2	events	0			0 /	not stated; modified itt; nausea/vomiting; R0007546:Results