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Coronary Artery StenosisPhase 2BLASTNCT00739466

Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

A Phase 2 study testing Liposomal Alendronate in people with Coronary Artery Stenosis, run by BIOrest Ltd. at 12 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Stenosis
What is being tested?
Liposomal Alendronate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
12 sitesIsrael
Study dates
Sep 2008to Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is eligible for percutaneous coronary intervention .
  • Subject is an acceptable candidate for coronary artery bypass graft surgery.
  • Subject has stable angina pectoris
  • Subject is a candidate for elective stenting of up to 2 lesions.

Who cannot join

  • General
  • Any planned elective surgery or percutaneous intervention within 6 months post-procedure.
  • A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
  • Subject requires a staged procedure of either the target or any non-target vessel within 9 months post-procedure.
  • Any drug eluting stent (DES) deployment within the past 12 months.
  • Any planned drug eluting stent (DES) deployment during the procedure associated with this study or within 3 months following the index procedure.
Show all 30Show fewer
  • Known hypersensitivity or contraindication to aspirin or clopidogrel or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • Documented left ventricular ejection fraction (LVEF) < 25% at the most recent evaluation.
  • 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.
  • History of cerebrovascular accident or transient ischemic attack in the last 6 months.
  • Leukopenia .
  • Neutropenia
  • Thrombocytopenia
  • Serum creatinine level >2.5 mg/dl within 7 days prior to index procedure.
  • History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  • 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.
  • History of severe:Gastrointestinal disease,Immunodeficiency,Bone diseases
  • Angiographic Exclusion Criteria
  • 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).
  • Any previous stent placement within 15 mm (proximal or distal) of the target lesion(s).
  • 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.
  • Target lesion(s) exhibiting an intraluminal thrombus (occupying >50% of the true lumen diameter) at any time.
  • Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
  • 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.).
  • Target lesion(s) with side branches > 2.0mm in diameter.
  • Target lesion(s) involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
  • Target lesion(s) with severe calcification.
  • Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion(s).
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Israel12 sites

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Bnei Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 31096

  • Lady Davis Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Meir Medical Center

    Kfar Saba, 44281

  • Western Galilee Hospital, Nahariya

    Nahariya, 22100

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Baruch Padeh Medical Center, Poriya

    Poria – Neve Oved, 15218

  • Sheba Medical Center, Tel Hashomer

    Ramat Gan, 52521

  • Kaplan Medical Center

    Rehovot, 76100

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

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

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.

Read the 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.

Being tested
Liposomal Alendronate, Saline infusion (placebo)
Keywords
Liposomal Alendronate, Percutaneous coronary intervention, Coronary stenting, de novo stenotic lesions, Native coronary arteries, Restenosis, Bare metal stent, Presillion CoCr coronary stent
Medical subject headings
Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal AlendronateDrug

    Also called LA

    IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours

  • Liposomal AlendronateDrug

    Also called LA

    IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours

  • Saline infusion (placebo)Drug

    Also called Saline

    IV saline infusion during the index procedure (coronary stent implantation) over 2 hours

Study groups in NCT00739466
Study groupRoleWhat they receive
low doseExperimentalLiposomal Alendronate dose of 0.001 mg
Receives: Drug: Liposomal Alendronate
high doseExperimentalLiposomal Alendronate dose of 0.01 mg
Receives: Drug: Liposomal Alendronate
placeboPlacebo comparatorIV saline infusion
Receives: Drug: Saline infusion (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent late loss: measured at 6 months post-procedure as determined by quantitative coronary angiography (QCA).

    Measured: 6 months post-procedure

Secondary outcomes (1)

  1. Major Adverse Cardiac Events (MACE)

    Measured: at 30, 180 and 360 days as well as yearly through 5 years post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739466
Sponsor's protocol ID
LA-II-01
Acronym
BLAST
Status last verified
Jan 2016
First submitted
20 Aug 2008
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Banai S, Finkelstein A, Almagor Y, Assali A, Hasin Y, Rosenschein U, Apruzzese P, Lansky AJ, Kume T, Edelman ER. Targeted anti-inflammatory systemic therapy for restenosis: the Biorest Liposomal Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical trial. Am Heart J. 2013 Feb;165(2):234-40.e1. doi: 10.1016/j.ahj.2012.10.023. Epub 2012 Dec 11.

    PubMed 23351827

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liposomal Alendronate in people with Coronary Artery Stenosis, run by BIOrest Ltd. at 12 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent late loss: measured at 6 months post-procedure as determined by quantitative coronary angiography (QCA). (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00739466, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016; AzTrials last refreshed its copy on 31 Oct 2026.

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