Full Text View
Tabular View
No Study Results Posted
Related Studies
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
This study is currently recruiting participants.
Verified by BIOrest Ltd., June 2009
First Received: August 20, 2008   Last Updated: June 1, 2009   History of Changes
Sponsor: BIOrest Ltd.
Collaborators: Harvard Clinical Research Institute
Cardiovascular Research Foundation, New York
Stanford University
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

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

Resource links provided by NLM:


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 Recruiting
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 Recruiting
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 Recruiting
Petah Tikva, Israel, 49100
Contact: Nurit Shor, RN     +972-39376437     nshor@clalit.org.il    
Principal Investigator: Prof Ran Kornowski, MD            
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Margalit Ben Tzvi, RN     +972-4-8543476     M_bentzvi@rambam.health.gov.il    
Principal Investigator: Dr Arthur Kerner, MD            
Lady Davis Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Rita Yuval, RN     +972-4-8250808     yrita@clalit.org.il    
Principal Investigator: Prof Basil Lewis, MD            
Bnei Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Smadar Harel     +972-4-8359395     Smadar.harel@b-zion.org.il    
Principal Investigator: Prof Uri Rosenschein, MD            
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Ilana Aloni     +972-4-6304487     IlanaA@hy.health.gov.il    
Principal Investigator: Dr. Aaron Frimerman, MD            
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Astrid Rojansky     +972-2-6555956     astrid@szmc.org.il    
Principal Investigator: Dr. Yaron Almagor, MD            
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Gladys Riveline     +972-8-9441335     Gladysri@clalit.org.il    
Principal Investigator: Dr. Oded Ayzenberg, MD            
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Shikma Hacham     +972-9-7471603     Shikma.Hacham@clalit.org.il    
Principal Investigator: Dr. Eliezer Rozenbaum, MD            
Western Galilee Hospital, Nahariya Recruiting
Nahariya, Israel, 22100
Contact: Etti Lasri     +972-4-9107747     Etti.lasri@naharia.health.gov.il    
Principal Investigator: Dr. Shaul Atar, MD            
The Baruch Padeh Medical Center, Poriya Recruiting
Poriya, Israel, 15218
Contact: Ghasan Salameh, RN     +972-4-6652287     gsalameh@poria.health.gov.il    
Principal Investigator: Prof Yonathan Hasin, MD            
Sponsors and Collaborators
BIOrest Ltd.
Harvard Clinical Research Institute
Cardiovascular Research Foundation, New York
Stanford University
Investigators
Principal Investigator: Prof Shmuel Banai, MD The Tel Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: BIOrest Ltd. ( Yoram Richter, PhD - VP R&D )
Study ID Numbers: LA-II-01
Study First Received: August 20, 2008
Last Updated: June 1, 2009
ClinicalTrials.gov Identifier: NCT00739466     History of Changes
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

Additional relevant MeSH terms:
Coronary Disease
Alendronate
Myocardial Ischemia
Physiological Effects of Drugs
Heart Diseases
Vascular Diseases
Bone Density Conservation Agents
Cardiovascular Diseases
Coronary Stenosis
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2010