Oral Sirolimus for In-Stent Restenosis - Full Text View

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00859183

Purpose

Despite recent advances in interventional cardiology including the success of drug-eluting stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a challenging clinical issue. Given the efficacy of the systemic sirolimus administration to prevent neointimal hyperplasia in animal models and to halt and even reverse the progression of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was to evaluate the efficacy of a 10-day oral sirolimus treatment with two different loading regimens for the prevention of recurrent restenosis in patients with in-stent restenosis.

Condition	Intervention	Phase
Coronary Restenosis	Drug: Sirolimus Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Impact of Oral Sirolimus on Restenosis Prevention in Patients With In-Stent Restenosis.

Resource links provided by NLM:

Drug Information available for: Sirolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Angiographic restenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The combined incidence of death and myocardial infarction as well as target vessel revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	300
Study Start Date:	October 2001
Study Completion Date:	March 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 cumulative loading dose of 8 mg of sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days	Drug: Sirolimus cumulative loading dose of 8 mg of oral sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days Other Name: Rapamune
Active Comparator: 2 cumulative loading dose of 24 mg of oral sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days	Drug: Sirolimus cumulative loading dose of 24 mg of oral sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days Other Name: Rapamune
Placebo Comparator: 3 oral placebo	Drug: Placebo Placebo oral Other Name: Placebo

Detailed Description:

Three-hundred symptomatic patients with in-stent restenotic lesions were randomly assigned to one of three treatment arms: placebo, usual dose or high dose sirolimus. Patients received a cumulative loading dose of 0, 8 or 24 mg of sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days. Angiographic restenosis at 6-months angiography was the primary end point of the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with angina pectoris or exercise-induced ischemia in the presence of angiographically significant in-stent-restenosis in native coronary arteries.

Exclusion Criteria:

Patients with acute coronary syndromes or with severe infectious diseases the presence of severe kidney failure (serum creatinine > 2.2 mg/dl) contraindications to sirolimus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859183

Locations

Germany
Medizinische Klinik I, Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany
Deutsches Herzzentrum
Munich, Germany, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Principal Investigator:	Adnan Kastrati, MD	Deutsches Herzzentrum Muenchen
Study Chair:	Albert Schömig, MD	Deutsches Herzzentrum Muenchen

More Information

Publications:

Hausleiter J, Kastrati A, Mehilli J, Vogeser M, Zohlnhöfer D, Schühlen H, Goos C, Pache J, Dotzer F, Pogatsa-Murray G, Dirschinger J, Heemann U, Schömig A; OSIRIS Investigators. Randomized, double-blind, placebo-controlled trial of oral sirolimus for restenosis prevention in patients with in-stent restenosis: the Oral Sirolimus to Inhibit Recurrent In-stent Stenosis (OSIRIS) trial. Circulation. 2004 Aug 17;110(7):790-5. Epub 2004 Aug 9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kufner S, Hausleiter J, Ndrepepa G, Schulz S, Bruskina O, Byrne RA, Fusaro M, Kastrati A, Schömig A, Mehilli J; OSIRIS Trial Investigators. Long-term risk of adverse outcomes and new malignancies in patients treated with oral sirolimus for prevention of restenosis. JACC Cardiovasc Interv. 2009 Nov;2(11):1142-8.

Responsible Party:	Albert Schömig, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00859183 History of Changes
Other Study ID Numbers:	GE IDE No. S01101
Study First Received:	March 6, 2009
Last Updated:	March 9, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:

in-stent restenosis
stents
sirolimus

Additional relevant MeSH terms:

Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012