drugset / Trial / NCT01969890
STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial
Phase 3
Terminated
532 enrolled
Heart Care Foundation
A. Manzoni Hospital · collabCentro Cardiologico Monzino · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to demonstrate that granulocyte colony-stimulating factor (G-CSF) therapy in addition to state-of-the-art treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patients with reduced left ventricular ejection fraction (LVEF) (≤45%) after successful reperfusion for large anterior acute myocardial infarction.
Timeline
- Start
- 2013-10
- Primary completion
- 2018-05
- Completion
- 2018-05
Outcome
Missed primary endpoint
Stopped (Enrollment): “Upon DSMC suggestion due to a too low enrollment rate.”
paper No difference was found in the composite primary outcome between study groups (HR 1.20; 95% CI 0.63 to 2.28). PMID 39401872 ↗
Publications
- Background Achilli F, Malafronte C, Cesana F, Maggiolini S, Mauro C, De Ferrari GM, Lenatti L, Tespili M, Pasqualini P, Gentile F, Capogrossi MC, Maggioni A, Maseri A, Pontone G, Colombo GI, Pompilio G; STEM-AMI OUTCOME Trial Investigators. Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction: rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial. Am Heart J. 2015 Oct;170(4):652-658.e7. doi: 10.1016/j.ahj.2015.07.005. Epub 2015 Jul 12.
- Background Achilli F, Pontone G, Bassetti B, Squadroni L, Campodonico J, Corrada E, Facchini C, Mircoli L, Esposito G, Scarpa D, Pidello S, Righetti S, Di Gennaro F, Guglielmo M, Muscogiuri G, Baggiano A, Limido A, Lenatti L, Di Tano G, Malafronte C, Soffici F, Ceseri M, Maggiolini S, Colombo GI, Pompilio G; STEM-AMI OUTCOME CMR Sub-Study Investigators. G-CSF for Extensive STEMI. Circ Res. 2019 Jul 19;125(3):295-306. doi: 10.1161/CIRCRESAHA.118.314617. Epub 2019 May 29.
- Achilli F, Maggiolini S, Madotto F, Bassetti B, Gentile F, Maggioni AP, Colombo GI, Pompilio G; STEM-AMI OUTCOME Trial Investigators. Granulocyte colony-stimulating factor for stem cell mobilisation in acute myocardial infarction: a randomised controlled trial. Heart. 2024 Oct 28;110(22):1316-1326. doi: 10.1136/heartjnl-2024-323926.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | G-CSF | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |