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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 |
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 |
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 |
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
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Drug: Liposomal Alendronate
IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
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high dose: Experimental
Liposomal Alendronate dose of 0.01 mg
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Drug: Liposomal Alendronate
IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours
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placebo: Placebo Comparator
IV saline infusion
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Drug: Saline infusion (placebo)
IV saline infusion during the index procedure (coronary stent implantation) over 2 hours
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
General
Angiographic Exclusion Criteria
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 |
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 |
BIOrest Ltd. |
Harvard Clinical Research Institute (HCRI) |
Cardiovascular Research Foundation, New York |
Stanford University Medical Center Division of Cardiology |
Principal Investigator: | Prof Shmuel Banai, MD | The Tel Aviv Sourasky Medical Center |
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 |
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