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Oral Sirolimus for In-Stent Restenosis (OSIRIS)

Primary Purpose

Coronary Restenosis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Sirolimus
Sirolimus
Placebo
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Restenosis focused on measuring in-stent restenosis, stents, sirolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik I, Garmisch-Partenkirchen
  • Deutsches Herzzentrum
  • 1. Medizinische Klinik, Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

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

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

oral placebo

Outcomes

Primary Outcome Measures

Angiographic restenosis

Secondary Outcome Measures

The combined incidence of death and myocardial infarction as well as target vessel revascularization

Full Information

First Posted
March 6, 2009
Last Updated
March 9, 2009
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00859183
Brief Title
Oral Sirolimus for In-Stent Restenosis
Acronym
OSIRIS
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Impact of Oral Sirolimus on Restenosis Prevention in Patients With In-Stent Restenosis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Restenosis
Keywords
in-stent restenosis, stents, sirolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
oral placebo
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral
Primary Outcome Measure Information:
Title
Angiographic restenosis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The combined incidence of death and myocardial infarction as well as target vessel revascularization
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert Schömig, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
Facility Information:
Facility Name
Medizinische Klinik I, Garmisch-Partenkirchen
City
Garmisch-Partenkirchen
Country
Germany
Facility Name
Deutsches Herzzentrum
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
1. Medizinische Klinik, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15302787
Citation
Hausleiter J, Kastrati A, Mehilli J, Vogeser M, Zohlnhofer D, Schuhlen H, Goos C, Pache J, Dotzer F, Pogatsa-Murray G, Dirschinger J, Heemann U, Schomig 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. doi: 10.1161/01.CIR.0000138935.17503.35. Epub 2004 Aug 9.
Results Reference
result
PubMed Identifier
19926058
Citation
Kufner S, Hausleiter J, Ndrepepa G, Schulz S, Bruskina O, Byrne RA, Fusaro M, Kastrati A, Schomig 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. doi: 10.1016/j.jcin.2009.08.015.
Results Reference
derived

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Oral Sirolimus for In-Stent Restenosis

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