Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
BLAST
Intravenous Liposomal Alendronate Infusion in Subjects Undergoing Bare Metal Coronary Stent Implantation
1 other identifier
interventional
226
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2008
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 21, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 20, 2016
January 1, 2016
7.3 years
August 20, 2008
January 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-stent late loss: measured at 6 months post-procedure as determined by quantitative coronary angiography (QCA).
6 months post-procedure
Secondary Outcomes (1)
Major Adverse Cardiac Events (MACE)
at 30, 180 and 360 days as well as yearly through 5 years post-procedure
Study Arms (3)
low dose
EXPERIMENTALLiposomal Alendronate dose of 0.001 mg
high dose
EXPERIMENTALLiposomal Alendronate dose of 0.01 mg
placebo
PLACEBO COMPARATORIV saline infusion
Interventions
IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
IV saline infusion during the index procedure (coronary stent implantation) over 2 hours
Eligibility Criteria
You may qualify if:
- Subject is eligible for percutaneous coronary intervention .
- Subject is an acceptable candidate for coronary artery bypass graft surgery.
- Subject has stable angina pectoris
- Subject is a candidate for elective stenting of up to 2 lesions.
You may not qualify if:
- General
- Any planned elective surgery or percutaneous intervention within 6 months post-procedure.
- A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
- Subject requires a staged procedure of either the target or any non-target vessel within 9 months post-procedure.
- Any drug eluting stent (DES) deployment within the past 12 months.
- Any planned drug eluting stent (DES) deployment during the procedure associated with this study or within 3 months following the index procedure.
- Known hypersensitivity or contraindication to aspirin or clopidogrel or a sensitivity to contrast media, which cannot be adequately pre-medicated
- Concurrent medical condition with a life expectancy of less than 12 months.
- Documented left ventricular ejection fraction (LVEF) \< 25% at the most recent evaluation.
- Evidence of ST elevated myocardial infarction (STEMI) or non-STEMI with troponin (cTn) levels greater than or equal to 3 times the normal limit at any time within 72 hours of the intended trial procedure.
- History of cerebrovascular accident or transient ischemic attack in the last 6 months.
- Leukopenia .
- Neutropenia
- Thrombocytopenia
- Serum creatinine level \>2.5 mg/dl within 7 days prior to index procedure.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BIOrest Ltd.lead
- Baim Institute for Clinical Researchcollaborator
- Cardiovascular Research Foundation, New Yorkcollaborator
- Stanford Universitycollaborator
Study Sites (12)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
Bnei Zion Medical Center
Haifa, 31048, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Lady Davis Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Western Galilee Hospital, Nahariya
Nahariya, 22100, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
The Baruch Padeh Medical Center, Poriya
Poria – Neve Oved, 15218, Israel
Sheba Medical Center, Tel Hashomer
Ramat Gan, 52521, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Related Publications (1)
Banai S, Finkelstein A, Almagor Y, Assali A, Hasin Y, Rosenschein U, Apruzzese P, Lansky AJ, Kume T, Edelman ER. Targeted anti-inflammatory systemic therapy for restenosis: the Biorest Liposomal Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical trial. Am Heart J. 2013 Feb;165(2):234-40.e1. doi: 10.1016/j.ahj.2012.10.023. Epub 2012 Dec 11.
PMID: 23351827DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Shmuel Banai, MD
The Tel Aviv Sourasky Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 21, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 20, 2016
Record last verified: 2016-01