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Status:

COMPLETED

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

Lead Sponsor:

Deutsches Herzzentrum Muenchen

Conditions:

Coronary Heart Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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

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 a...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2006

Estimated Enrollment :

502 Patients enrolled

Trial Details

Trial ID

NCT00402636

Start Date

March 1 2005

End Date

October 1 2006

Last Update

November 28 2007

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Deutsches Herzzentrum Muenchen

Munich, Germany, 80636

2

1. Medizinische Klinik, Klinikum rechts der Isar

München, Germany, 81675