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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 22, 2006
Last Update Posted: November 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Deutsches Herzzentrum Muenchen
The purpose of this study is to evaluate whether adding estradiol to rapamycin better prevents coronary artery reblockage after drug-eluting stent implantation.

Condition Intervention Phase
Coronary Heart Disease Device: rapamycin plus 17beta estradiolvalerat-eluting stent Device: rapamycin-eluting stent Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Trial of Rapamycin Plus Estradiol-Eluting Stents Versus Rapamycin-Eluting Stents For The Reduction of Coronary Restenosis (ISAR-PEACE)

Resource links provided by NLM:

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • in-stent late luminal loss [ Time Frame: 6 months ]

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

Enrollment: 502
Study Start Date: March 2005
Study Completion Date: October 2006
Arms Assigned Interventions
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

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402636

1. Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Study Chair: Albert Schoemig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
  More Information

Adriaenssens T, Mehilli J, Wessely R, Ndrepepa G, Seyfarth M, Wieczorek A, Blaich B, Iijima R, Pache J, Kastrati A, Schömig A. Does addition of estradiol improve the efficacy of a rapamycin-eluting stent? Results of the ISAR-PEACE randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1265-71. Erratum in: J Am Coll Cardiol. 2007 May 8;49(18):1902.
Sousa JE, Serruys PW, Costa MA. New frontiers in cardiology: drug-eluting stents: Part I. Circulation. 2003 May 6;107(17):2274-9. Review.
Babapulle MN, Joseph L, Bélisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet. 2004 Aug 14-20;364(9434):583-91.
Kastrati A, Dibra A, Eberle S, Mehilli J, Suárez de Lezo J, Goy JJ, Ulm K, Schömig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005 Aug 17;294(7):819-25.
Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30.
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21.
Wessely R, Kastrati A, Schömig A. Late restenosis in patients receiving a polymer-coated sirolimus-eluting stent. Ann Intern Med. 2005 Sep 6;143(5):392-4. Epub 2005 Aug 16.
Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. Epub 2004 Jan 26.
Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schömig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. Epub 2005 Jun 23.
Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schömig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006 Jan 17;113(2):273-9. Epub 2006 Jan 3.
Wessely R, Hausleiter J, Michaelis C, Jaschke B, Vogeser M, Milz S, Behnisch B, Schratzenstaller T, Renke-Gluszko M, Stöver M, Wintermantel E, Kastrati A, Schömig A. Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):748-53. Epub 2005 Jan 27. Erratum in: Arterioscler Thromb Vasc Biol. 2005 Aug;25(8):e130.
Dibra A, Kastrati A, Mehilli J, Pache J, Schühlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schömig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. Epub 2005 Aug 16.
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23.
Abizaid A, Albertal M, Costa MA, Abizaid AS, Staico R, Feres F, Mattos LA, Sousa AG, Moses J, Kipshidize N, Roubin GS, Mehran R, New G, Leon MB, Sousa JE. First human experience with the 17-beta-estradiol-eluting stent: the Estrogen And Stents To Eliminate Restenosis (EASTER) trial. J Am Coll Cardiol. 2004 Mar 17;43(6):1118-21.

ClinicalTrials.gov Identifier: NCT00402636     History of Changes
Other Study ID Numbers: GE IDE No. S02505
First Submitted: November 21, 2006
First Posted: November 22, 2006
Last Update Posted: November 28, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors

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