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| 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: | 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 |
| 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 |
|---|---|
|
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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
General
Angiographic Exclusion Criteria
Contacts and Locations| Israel | |
| Hillel Yaffe Medical Center | |
| Hadera, Israel, 38100 | |
| Lady Davis Carmel Medical Center | |
| Haifa, Israel, 34362 | |
| Rambam Health Care Campus | |
| Haifa, Israel, 31096 | |
| Bnei Zion Medical Center | |
| Haifa, Israel, 31048 | |
| 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 | |
| Principal Investigator: | Prof Shmuel Banai, MD | The Tel Aviv Sourasky Medical Center |
More Information
| Responsible Party: | BIOrest Ltd. ( Yoram Richter, PhD - VP R&D ) |
| 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 |
|
Liposomal Alendronate Percutaneous coronary intervention Coronary stenting de novo stenotic lesions |
Native coronary arteries Restenosis Bare metal stent Presillion CoCr coronary stent |
|
Coronary Stenosis Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Alendronate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |