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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University of Rome Tor Vergata.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Milan
Information provided by:
University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT00484965
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Acute-Phase Reaction
Procedure: Coronary stenting
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Erythrocyte-Mediated Drug Delivery for the Prevention of Restenosis After Coronary Artery Stent Implantation:TROY-Study

Resource links provided by NLM:


Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Reduction of myointimal proliferation and restenosis after stenting implantation [ Time Frame: one year ]

Estimated Enrollment: 100
Study Start Date: July 2007
Estimated Study Completion Date: January 2009
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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484965

Contacts
Contact: Francesco Versaci, MD, FACC +390620903536 francescoversaci@yahoo.it
Contact: Costantino Del Giudice, MD +390620903536 costantino.delgiudice@yahoo.it

Locations
Italy
Policlinico Tor Vergata Not yet recruiting
Rome, Italy, 00133
Contact: Luigi Chiariello, MD, FACC    +390620903536    francescoversaci@yahoo.it   
Contact: Francesco Versaci, MD, FACC    +390620903536    francescoversaci@yahoo.it   
Principal Investigator: Francesco Versaci, MD, FACC         
Sub-Investigator: Costantino Del Giudice, MD         
Principal Investigator: Luigi Chiariello, MD, FACC         
Sponsors and Collaborators
University of Rome Tor Vergata
University of Milan
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00484965     History of Changes
Other Study ID Numbers: 72/06
Study First Received: June 11, 2007
Last Updated: June 11, 2007
Health Authority: Italy: Ethics Committee

Keywords provided by University of Rome Tor Vergata:
Coronary stent
Inflammation
Atherosclerosis
Immunosuppressive

Additional relevant MeSH terms:
Acute-Phase Reaction
Atherosclerosis
Inflammation
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014