ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

This study is not yet open for participant recruitment.
Verified by BIOrest Ltd., August 2008

Sponsors and Collaborators: BIOrest Ltd.
Harvard Clinical Research Institute (HCRI)
Cardiovascular Research Foundation, New York
Stanford University Medical Center Division of Cardiology
Information provided by: BIOrest Ltd.
ClinicalTrials.gov Identifier: NCT00739466
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Drug: Liposomal Alendronate
Drug: Saline infusion (placebo)
Phase II

ChemIDplus related topics:   Alendronate    Alendronate sodium    Sodium chloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:   Intravenous Liposomal Alendronate Infusion in Subjects Undergoing Bare Metal Coronary Stent Implantation

Further study details as provided by BIOrest Ltd.:

Primary Outcome Measures:
  • In-stent late loss: measured at 6 months post-procedure as determined by quantitative coronary angiography (QCA). [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) [ Time Frame: at 30, 180 and 360 days as well as yearly through 5 years post-procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   219
Study Start Date:   September 2008
Estimated Study Completion Date:   April 2014
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
low dose: Experimental
Liposomal Alendronate dose of 0.001 mg
Drug: Liposomal Alendronate
IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
high dose: Experimental
Liposomal Alendronate dose of 0.01 mg
Drug: Liposomal Alendronate
IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours
placebo: Placebo Comparator
IV saline infusion
Drug: Saline infusion (placebo)
IV saline infusion during the index procedure (coronary stent implantation) over 2 hours

Detailed Description:

This is a Phase II dose-finding, randomized, multi-center, prospective, double blind clinical study. Subjects undergoing percutaneous coronary intervention (PCI) with the Presillion™ CoCr bare metal stent will be randomized into three groups and administered (in a single dose intravenously (IV) through a peripheral venous catheter) either: low dose Liposomal Alendronate of 0.001 mg, high dose Liposomal Alendronate of 0.01 mg, or placebo (IV saline infusion) on a 1:1:1 basis.

All subjects will undergo angiographic follow-up at 6 months and 110 subjects enrolled from pre-specified sites will undergo intravascular ultrasound (IVUS) at baseline and follow-up at 6 months.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Subject is eligible for percutaneous coronary intervention .
  2. Subject is an acceptable candidate for coronary artery bypass graft surgery.
  3. Subject has stable angina pectoris
  4. Subject is a candidate for elective stenting of up to 2 lesions.

Exclusion Criteria:

General

  1. Any planned elective surgery or percutaneous intervention within 6 months post-procedure.
  2. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
  3. Subject requires a staged procedure of either the target or any non-target vessel within 9 months post-procedure.
  4. Any drug eluting stent (DES) deployment within the past 12 months.
  5. Any planned drug eluting stent (DES) deployment during the procedure associated with this study or within 3 months following the index procedure.
  6. Known hypersensitivity or contraindication to aspirin or clopidogrel or a sensitivity to contrast media, which cannot be adequately pre-medicated
  7. Concurrent medical condition with a life expectancy of less than 12 months.
  8. Documented left ventricular ejection fraction (LVEF) < 25% at the most recent evaluation.
  9. 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.
  10. History of cerebrovascular accident or transient ischemic attack in the last 6 months.
  11. Leukopenia .
  12. Neutropenia
  13. Thrombocytopenia
  14. Serum creatinine level >2.5 mg/dl within 7 days prior to index procedure.
  15. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  16. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy, Alendronate or sensitivity to contrast media, which cannot be adequately pre-medicated.
  17. History of severe:Gastrointestinal disease,Immunodeficiency,Bone diseases

Angiographic Exclusion Criteria

  1. Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
  2. Any previous stent placement within 15 mm (proximal or distal) of the target lesion(s).
  3. Target vessel exhibiting lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion(s) based on visual estimate or on-line QCA.
  4. Target lesion(s) exhibiting an intraluminal thrombus (occupying >50% of the true lumen diameter) at any time.
  5. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
  6. The target lesion(s) requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
  7. Target lesion(s) with side branches > 2.0mm in diameter.
  8. Target lesion(s) involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
  9. Target lesion(s) with severe calcification.
  10. Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion(s).
  11. Target lesion(s) located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739466

Contacts
Contact: Olivia Mishall, RN, BSc, MBA     +972-3-7679000 ext 247     oliviam@medinol.com    
Contact: Hana Monsonego, BSc     +972-3-7679000 ext 246     hana@medinol.com    

Locations
Israel
The Tel Aviv Sourasky Medical Center    
      Tel Aviv, Israel, 64239
      Contact: Miri Revivo     972-3-6947520     mirire@tasmc.health.gov.il    
      Principal Investigator: Prof Shmuel Banai, MD            
Sheba Medical Center, Tel Hashomer    
      Ramat Gan, Israel, 52521
      Contact: Nava Eizenberg, RN     +972-3-5302617     Nava.eizenberg@sheba.health.gov    
      Principal Investigator: Dr. Victor Guetta, MD            
Rabin Medical Center    
      Petah Tikva, Israel, 49100
      Contact: Nurit Shor, RN     +972-39376437     nshor@clalit.org.il    
      Principal Investigator: Prof Ran Kornowski, MD            
The Baruch Padeh Medical Center, Poriya    
      Poriya, Israel, 15218
      Contact: Ghasan Salameh, RN     +972-4-6652287     gsalameh@poria.health.gov.il    
      Principal Investigator: Prof Yonathan Hasin, MD            
Lady Davis Carmel Medical Center    
      Haifa, Israel, 34362
      Contact: Rita Yuval, RN     +972-4-8250808     yrita@clalit.org.il    
      Principal Investigator: Prof Basil Lewis, MD            
Bnei Zion Medical Center    
      Haifa, Israel, 31048
      Contact: Smadar Harel     +972-4-8359395     Smadar.harel@b-zion.org.il    
      Principal Investigator: Prof Uri Rosenschein, MD            
Rambam Health Care Campus    
      Haifa, Israel, 31096
      Contact: Margalit Ben Tzvi, RN     +972-4-8543476     M_bentzvi@rambam.health.gov.il    
      Principal Investigator: Dr Arthur Kerner, MD            

Sponsors and Collaborators
BIOrest Ltd.
Harvard Clinical Research Institute (HCRI)
Cardiovascular Research Foundation, New York
Stanford University Medical Center Division of Cardiology

Investigators
Principal Investigator:     Prof Shmuel Banai, MD     The Tel Aviv Sourasky Medical Center    
  More Information


Responsible Party:   BIOrest Ltd. ( Yoram Richter, PhD - VP R&D )
Study ID Numbers:   LA-II-01
First Received:   August 20, 2008
Last Updated:   August 20, 2008
ClinicalTrials.gov Identifier:   NCT00739466
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by BIOrest Ltd.:
Liposomal Alendronate  
Percutaneous coronary intervention  
Coronary stenting  
de novo stenotic lesions  
Native coronary arteries
Restenosis
Bare metal stent
Presillion CoCr coronary stent

Study placed in the following topic categories:
Coronary Disease
Heart Diseases
Alendronate
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Coronary Stenosis

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers