Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

Coronary Artery Stenosis Clinical Trial

— BLAST  

Official title:

Intravenous Liposomal Alendronate Infusion in Subjects Undergoing Bare Metal Coronary Stent Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739466
• Other study ID #: LA-II-01
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: January 17, 2016
• Start date: September 2008
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: BIOrest Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Drug:
• Liposomal Alendronate
IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
• Liposomal Alendronate
IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours
• Saline infusion (placebo)
IV saline infusion during the index procedure (coronary stent implantation) over 2 hours

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Bnei Zion Medical Center	Haifa
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Western Galilee Hospital, Nahariya	Nahariya
Israel	Rabin Medical Center	Petah Tikva
Israel	The Baruch Padeh Medical Center, Poriya	Poriya
Israel	Sheba Medical Center, Tel Hashomer	Ramat Gan
Israel	Kaplan Medical Center	Rehovot
Israel	The Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (4)

Lead Sponsor	Collaborator
BIOrest Ltd.	Cardiovascular Research Foundation, New York, Harvard Clinical Research Institute, Stanford University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late loss: measured at 6 months post-procedure as determined by quantitative coronary angiography (QCA).		6 months post-procedure	No
Secondary	Major Adverse Cardiac Events (MACE)		at 30, 180 and 360 days as well as yearly through 5 years post-procedure	Yes