BLADE-PCI
Research type
Research Study
Full title
The BLADE-PCI Trial (PHASE IIB LIPOSOMAL ALENDRONATE STUDY): Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention
IRAS ID
197930
Contact name
Yoram Richter
Contact email
Sponsor organisation
BIOrest, Ltd.
Eudract number
2015-005445-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Several prior studies have suggested that systemic inflammation and activation of the innate immune system, involving monocytes and macrophages, play a central role in the pathogenesis of restenosis after percutaneous coronary intervention (PCI). The hypothesis of the study is that inhibition of the inflammatory pathway involving monocytes and macrophages among patients with DM will decrease the neointimal proliferation at the site of DES implantation. The single administration of LABR-312 creates a temporary inhibition of blood monocytes lasting for a few days and returning to a normal level within one week. This transient effect allows for initial inhibition of the excessive inflammatory response related to stent implantation and involved in restenosis, followed by a return to normal physiological activity, leading to normal vessel healing.
As patients with DM are known to be in a higher inflammatory state than non-DM patients and acknowledging the still high rate of adverse ischemic events among DM patients undergoing PCI, it is hypothesized that LABR-312 administration at the time of PCI will reduce restenosis compared with placebo in this population.
The study will assess the dose response curve of LABR-312, three different doses will be tested sequentially 0.01 mg (low dose), up to 0.03 mg (intermediate dose) and up to 0.08 mg (high dose).
This is a phase IIb, prospective, multi-center, multi-national, randomized, double-blind, two-arm, 1:1 (escalating dose LABR-312 vs. placebo) clinical trial. In both study arms, all target lesions will be treated with the Resolute Drug Eluting Stent. Subjects will be randomized to receive either the study drug LABR-312 or the placebo. Conditionally to ongoing safety monitoring, dose escalation of LABR-312 in the study arm will be performed. If a decision is made not to dose escalate, recruitment willcontinue with the highest dose level deemed safe by the ongoing safety monitoring, until approximately 270 subjects are randomized. The duration of subject participation will be 1 year; clinical follow-up will be performed at 30 days, 9 months, and 1 year post randomization. OCT follow-up will be performed at 9 months.REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0683
Date of REC Opinion
24 Jun 2016
REC opinion
Further Information Favourable Opinion