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Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Harvard Clinical Research Institute
Cardiovascular Research Foundation, New York
Stanford University
Information provided by:
BIOrest Ltd.
ClinicalTrials.gov Identifier:
NCT00739466
First received: August 20, 2008
Last updated: February 10, 2010
Last verified: February 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 226
Study Start Date: September 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low dose
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
Other Name: LA
Experimental: high dose
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
Other Name: LA
Placebo Comparator: placebo
IV saline infusion
Drug: Saline infusion (placebo)
IV saline infusion during the index procedure (coronary stent implantation) over 2 hours
Other Name: Saline

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Bnei Zion Medical Center
Haifa, Israel, 31048
Lady Davis Carmel Medical Center
Haifa, Israel, 34362
Rambam Health Care Campus
Haifa, Israel, 31096
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Meir Medical Center
Kfar Saba, Israel, 44281
Western Galilee Hospital, Nahariya
Nahariya, Israel, 22100
Rabin Medical Center
Petah Tikva, Israel, 49100
The Baruch Padeh Medical Center, Poriya
Poriya, Israel, 15218
Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel, 52521
Kaplan Medical Center
Rehovot, Israel, 76100
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
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 by BIOrest Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yoram Richter, PhD - VP R&D, BIOrest Ltd.
ClinicalTrials.gov Identifier: NCT00739466     History of Changes
Other Study ID Numbers: LA-II-01
Study First Received: August 20, 2008
Last Updated: February 10, 2010
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 Stenosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014