Rapamycin+Estradiol- vs. Rapamycin-Eluting Stents to Reduce Restenosis (ISAR-PEACE)

November 27, 2007 updated by: Deutsches Herzzentrum Muenchen

Prospective, Randomized Trial of Rapamycin Plus Estradiol-Eluting Stents Versus Rapamycin-Eluting Stents For The Reduction of Coronary Restenosis (ISAR-PEACE)

The purpose of this study is to evaluate whether adding estradiol to rapamycin better prevents coronary artery reblockage after drug-eluting stent implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neontimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence or absence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of permanent polymers in DESs, which have a proinflammatory and prothrombogenic potential, and sometimes may induce a hypersensitivity reaction. On the other hand, lack of or delayed reendothelialization is considered an important factor for development of coronary reblockage. Estradiol has been shown to promote rapid reendothelialization of the stent and to reduce the restenosis after PCI. This trial will compare the anti-restenotic efficacy of the polymer-free rapamycin plus 17β estradiolvalerat -eluting stent with that of the polymer-free rapamycin-eluting stent in patients with coronary artery disease. The ISAR stent is a rough surface stainless steel stent which allows coating without the need of polymer (PF ISAR stent) in the cath lab.

Study Type

Interventional

Enrollment (Actual)

502

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 Locations

  • Germany
      • Muenchen, Germany, 81675
        • 1. Medizinische Klinik, Klinikum rechts der Isar
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

  • Target lesion located in the left main trunk or bypass graft.
  • In-stent restenosis.
  • Acute ST-elevation myocardial infarction.
  • Cardiogenic shock.
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Known allergy to the study medications: aspirin, clopidogrel, rapamycin, estradiol, stainless steel.
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
rapamycin plus 17beta estradiolvalerat-eluting stent
Device: rapamycin plus 17beta estradiolvalerat-eluting stent
rapamycin plus 17beta estradiolvalerat-eluting stent was implanted due to randomisation
Experimental: 2
rapamycin-eluting stent
Device: rapamycin-eluting stent
rapamycin-eluting stent was implanted due to randomisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
in-stent late luminal loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
In-segment binary angiographic restenosis
Time Frame: 1 year
1 year
Need of target lesion revascularization
Time Frame: 1 year
1 year
Combined incidence of death or myocardial infarction
Time Frame: 1 year
1 year
Incidence of stent thrombosis.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

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.

General Publications

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

March 1, 2005

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

November 28, 2007

Last Update Submitted That Met QC Criteria

November 27, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. S02505

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.

Subscribe