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

NCT02645799 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2018-01-11

No results posted yet for this 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.

Conditions

Interventions

DRUG

LABR-312

administered intravenously at the time of percutaneous coronary intervention (PCI) with a drug eluting stent

DRUG

Saline (placebo)

administered intravenously at the time of percutaneous coronary intervention (PCI) with a drug eluting stent

Sponsors & Collaborators

  • BIOrest Ltd.

    lead INDUSTRY

Principal Investigators

  • Philippe Généreux, MD · Cardiovascular Research Foundation (CRF)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-08-31
Completion
2018-11-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT02645799 on ClinicalTrials.gov