Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

Phase 2 Completed 226 enrolled BIOrest Ltd. Baim Institute for Clinical Research · collab Cardiovascular Research Foundation, New York · collab Stanford University · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare metal stent. Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to placebo.

Timeline

Start: 2008-09
Primary completion: 2015-12
Completion: 2015-12

Outcome

Missed primary endpoint

paper For the overall cohort, there were no differences between the groups in the primary efficacy end point PMID 23351827 ↗

paper in-stent late loss of 0.86 ± 0.60 mm, 0.83 ± 0.57 mm, and 0.81 ± 0.68 mm for the placebo, low-dose, and high-dose group, respectively; P = not significant for all comparisons PMID 23351827 ↗

Publications

Banai S, Finkelstein A, Almagor Y, Assali A, Hasin Y, Rosenschein U, Apruzzese P, Lansky AJ, Kume T, Edelman ER. Targeted anti-inflammatory systemic therapy for restenosis: the Biorest Liposomal Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical trial. Am Heart J. 2013 Feb;165(2):234-40.e1. doi: 10.1016/j.ahj.2012.10.023. Epub 2012 Dec 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liposomal Alendronate	Unknown	0.001 mg	Intravenous
Subject	Liposomal Alendronate	Unknown	0.01 mg	Intravenous