factorial randomized trial

COMBAT-MI

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

COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial

Other conditions NCT02404376S000986

Design

Randomized: 378
Start year: 2016
Treatment: 0.04 weeks, follow-up 1 weeks
Countries: Spain (6 sites)
Sponsor: Vall d'Hebron Research Institute (non industry)
Eligibility: adults with STEMI within 6 hours, TIMI flow 0 or 1, primary PCI

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide Exenatide IV infusion (with RIC or sham)	primary PCI; half with remote ischemic conditioning; lifestyle: none	189	110
A2	Placebo Matching placebo infusion (with RIC or sham)	primary PCI; half with remote ischemic conditioning; lifestyle: none	189	112

Baseline characteristics

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

Characteristic	Statistic	Exenatide IV infusion (with RIC or sham) A1	Placebo A2
age	mean (years)	61.7	61.2
age	sd (years)	11.5	11
bmi	mean (kg/m2)	27.6	27.1
bmi	sd (kg/m2)	3.9	4
female	n	22	14
female	percent	20	12.5
metformin use	n	19	12
metformin use	percent	21.1	12.5
other diabetes treated	n	22	25
other diabetes treated	percent	20	22.3
other previous mi	n	0	4
other previous mi	percent	0	3.6