Sitagliptin Plus Granulocyte-colony Stimulating Factor in Acute Myocardial Infarction

Summary

Trial design: This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing routine percutaneous coronary revascularisation for acute myocardial infarction (time from onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group, n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function from baseline to 6 months of follow-up.

Timeline

Start

2008-03

Primary completion

2012-06

Completion

2013-06

Publications

• Background Engelmann MG, Theiss HD, Hennig-Theiss C, Huber A, Wintersperger BJ, Werle-Ruedinger AE, Schoenberg SO, Steinbeck G, Franz WM. Autologous bone marrow stem cell mobilization induced by granulocyte colony-stimulating factor after subacute ST-segment elevation myocardial infarction undergoing late revascularization: final results from the G-CSF-STEMI (Granulocyte Colony-Stimulating Factor ST-Segment Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2006 Oct 17;48(8):1712-21. doi: 10.1016/j.jacc.2006.07.044. Epub 2006 Sep 11.
• Brenner C, Adrion C, Grabmaier U, Theisen D, von Ziegler F, Leber A, Becker A, Sohn HY, Hoffmann E, Mansmann U, Steinbeck G, Franz WM, Theiss HD. Sitagliptin plus granulocyte colony-stimulating factor in patients suffering from acute myocardial infarction: A double-blind, randomized placebo-controlled trial of efficacy and safety (SITAGRAMI trial). Int J Cardiol. 2016 Feb 15;205:23-30. doi: 10.1016/j.ijcard.2015.11.180. Epub 2015 Nov 30.

Drugs

Indications