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

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ClinicalTrials.gov Identifier: NCT00402636
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : November 28, 2007
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen

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.

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

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  (Clinical Trial)
Actual Enrollment : 502 participants
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)
Study Start Date : March 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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


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

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.

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


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

Publications of Results:
Other Publications:

ClinicalTrials.gov Identifier: NCT00402636     History of Changes
Other Study ID Numbers: GE IDE No. S02505
First Posted: November 22, 2006    Key Record Dates
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
Arteriosclerosis
Arterial Occlusive Diseases
Estradiol
Sirolimus
Everolimus
Estrogens
Hormones
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