Erythrocyte-Mediated Drug Delivery for the Prevention of Stent Restenosis (TROY)

June 11, 2007 updated by: University of Rome Tor Vergata

Erythrocyte-Mediated Drug Delivery for the Prevention of Restenosis After Coronary Artery Stent Implantation:TROY-Study

The purpose of this study is to determine whether erythrocyte mediated dexamethasone delivery reduces circulating inflammatory markers after coronary stent implantation and improves clinical and angiographic outcomes.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

In stent restenosis is still an unsolved problem. We know that principally in stent restenosis depends on myointimal proliferation, a biological process in which inflammatory mechanisms play a central role. We have previously demonstrated that immunosuppressive therapy with prednisone administered for 45 days after the stenting procedure reduced the incidence of restenosis at six months and clinical events at 12 months in high risk patients, with persistent higher C reactive protein levels after stenting implantation. But this therapy needs a high dosage glucocorticoids, and this is a contraindication in some subset of patients i.e. diabetics.

Recently a new method for the encapsulation of drugs into human autologous erythrocytes using an apparatus and a disposable kit has been developed. It's well known that blood erythrocytes change their membrane properties when in contact with suspensions of different osmotic values. So we developed a method to modify erythrocytes membrane properties so that they became porous and be able to absorb and then release some specific molecules. Experimental studies demonstrated that non diffusible pro-drug 21-phosphate dexamethasone can be loaded in human blood erythrocytes and then slowly dephosphorylated to the corresponding diffusible molecule to be released in human plasma. Once in-vivo due to the presence of the hydrophilic phosphate group, Dex 21-P encapsulated into RBCs cannot diffuse through RBC membrane until it is slowly dephosphorylated to the corresponding active corticosteroid by erythrocytes resident enzymes. The novelty and the advantages of this procedure are that the red blood cells act as a slow and constant drug delivery system so that, during the 30 days after the administration, there is always a low level of corticosteroid in plasma. When these erythrocytes are reinfused in the donor, they release in a continuous way a low and constant level of drug. This procedure has yet been used in some chronic inflammatory disease (i.e. bowel disease) in more than 1600 patients, with significant clinical improvement. The main objective of the study is 1) to evaluate if autologous erythrocytes modified as bioreceptor may be used to release glucocorticoids in blood circulation and 2) to reduce acute inflammatory proteins after coronary stent implantation with clinical and angiographic outcomes improvement. For this purpose 100 patients undergoing coronary artery stent implantation will be prospectively randomized in two groups:

  1. group A: bare metal stent implantation and treatment by 50 ml of autologous erythrocytes charged with dexamethasone 21-P
  2. group B: bare metal stent implantation and treatment by 50 ml of autologous erythrocytes not charged with dexamethasone 21-P The results of two groups will be compared.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Rome, Italy, 00133
        • Policlinico Tor Vergata
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Versaci, MD, FACC
        • Sub-Investigator:
          • Costantino Del Giudice, MD
        • Principal Investigator:
          • Luigi Chiariello, MD, FACC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • coronary disease
  • written informed consent
  • coronary stenosis
  • CRP baseline levels < 0,5 mg/dl

Exclusion Criteria:

  • acute myocardial infarction
  • coronary bypass grafting restenosis
  • vessels diameter < 2,5 mm
  • corticosteroids contraindications
  • corticosteroids therapy 30 days before
  • active infective disease
  • connective disease
  • pregnancy
  • cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine whether erythrocyte mediated dexamethasone delivery reduces circulating inflammatory markers after coronary stent implantation and improves reduction of acute phase reaction proteins
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of myointimal proliferation and restenosis after stenting implantation
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Francesco Versaci, MD, FACC, Tor Vergata University, Rome
  • Study Director: Francesco Versaci, MD, FACC, Tor Vergata University, Rome
  • Study Chair: Luigi Chiariello, MD, FACC, Tor Vergata University, Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Completion (ANTICIPATED)

January 1, 2009

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (ESTIMATE)

June 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2007

Last Update Submitted That Met QC Criteria

June 11, 2007

Last Verified

June 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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