BLADE-PCI Trial (BLADE); PHASE IIB LIPOSOMAL ALENDRONATE STUDY

Summary

The main objective of this study is to assess the safety, efficacy and dose response of LABR-312 administered intravenously at the time of percutaneous coronary intervention (PCI) with a drug eluting stent in reducing restenosis as measured by Optical Coherence Tomography (OCT) at 9 months post procedure in patients with diabetes mellitus (DM). Administration of LABR-312 at the time of PCI will reduce restenosis compared with placebo as assessed by the OCT endpoint of % neointimal hyperplasia (%NIH) volume at 9 months in patients with DM.

Timeline

Start

2016-04

Primary completion

2018-08

Completion

2018-11

Publications

• Genereux P, Chernin G, Assali AR, Peruga JZ, Robinson SD, Schampaert E, Bagur R, Mansour S, Rodes-Cabau J, McEntegart M, Gerber R, L'Allier P, de Silva R, Daneault B, Aggarwal SK, Dzavik V, Ozan MO, Ben-Yehuda O, Maehara A, Stone GW, Jonas M. Double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing PCI: The BLADE-PCI trial. Am Heart J. 2022 Jul;249:45-56. doi: 10.1016/j.ahj.2022.03.004. Epub 2022 Mar 17.

Drugs

Indications