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Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

NCT00739466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2016-01-20

No results posted yet for this study

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.

Conditions

  • Coronary Artery Stenosis

Interventions

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

Sponsors & Collaborators

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • BIOrest Ltd.

    lead INDUSTRY

Principal Investigators

  • Prof Shmuel Banai, MD · The Tel Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Israel

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00739466 on ClinicalTrials.gov