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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: | 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
|
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| 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 | 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 | |
| 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 |
| 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 |
|
Liposomal Alendronate Percutaneous coronary intervention Coronary stenting de novo stenotic lesions |
Native coronary arteries Restenosis Bare metal stent Presillion CoCr coronary stent |
|
Coronary Disease Alendronate Myocardial Ischemia Physiological Effects of Drugs Heart Diseases |
Vascular Diseases Bone Density Conservation Agents Cardiovascular Diseases Coronary Stenosis Pharmacologic Actions |