NCT02645799

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

Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: BIOrest Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 Integrity Drug Eluting Stent during the index PCI. Lesions that are planned to be treated must be declared and recorded at the time of randomization. Randomization will be stratified by the presence or absence of insulin treatment, HbA1c level (\<7.5% vs. ≥7.5%), and by pre-procedure monocyte count (≥500/uL or below). Subjects (n=\~270) 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: 0.01 mg (first 45 patients vs. 45 patients receiving placebo), up to 0.03 mg (next consecutive 45 patients vs. 45 patients receiving placebo) and up to 0.08 mg (final 45 consecutive patients vs. 45 patients receiving placebo). If a decision is made not to dose escalate, recruitment will continue with the highest dose level deemed safe by the ongoing safety monitoring, until approximately 270 subjects are randomized. In the LABR-312 group, 3 doses will therefore be tested, resulting in 6 possibilities: Group 1: Low dose 0.01 mg LABR-312 or equivalent volume of placebo (saline) administered IV. Group 2: Intermediate dose Up to 0.03 mg LABR-312 or equivalent volume of placebo (saline) administered IV. Group 3: High dose Up to 0.08 mg LABR-312 or equivalent volume of placebo (saline) administered IV. The duration of subject participation will be 1 year; clinical follow-up will be performed at 30 days, 9 months, and 1year post randomization. OCT follow-up will be performed at 9 months.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-08-01
• Completion: 2018-11-01
• First posted: 2016-01-05
• Last updated: 2018-01-11

Locations

1 site across 1 country: Israel