NCT00739466

Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

Intravenous Liposomal Alendronate Infusion in Subjects Undergoing Bare Metal Coronary Stent Implantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: BIOrest Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase II dose-finding, randomized, multi-center, prospective, double blind clinical study. Subjects undergoing percutaneous coronary intervention (PCI) with the Presillion™ CoCr bare metal stent will be randomized into three groups and administered (in a single dose intravenously (IV) through a peripheral venous catheter) either: low dose Liposomal Alendronate of 0.001 mg, high dose Liposomal Alendronate of 0.01 mg, or placebo (IV saline infusion) on a 1:1:1 basis. All subjects will undergo angiographic follow-up at 6 months and 110 subjects enrolled from pre-specified sites will undergo intravascular ultrasound (IVUS) at baseline and follow-up at 6 months.

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DRUG	Liposomal Alendronate	IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
DRUG	Liposomal Alendronate	IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours
DRUG	Saline infusion (placebo)	IV saline infusion during the index procedure (coronary stent implantation) over 2 hours

Timeline

• Start date: 2008-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2008-08-21
• Last updated: 2016-01-20

Locations

12 sites across 1 country: Israel