Diabetes Mellitus Clinical Trial
Official title:
Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention
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.
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.
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