Oral Sirolimus for In-Stent Restenosis

Coronary Restenosis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859183
• Other study ID #: GE IDE No. S01101
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2009
• Last updated: March 9, 2009
• Start date: October 2001
• Est. completion date: March 2004

Study information

• Verified date: March 2009
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

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
• 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
• Placebo
Placebo oral

Locations

Country	Name	City	State
Germany	Medizinische Klinik I, Garmisch-Partenkirchen	Garmisch-Partenkirchen
Germany	1. Medizinische Klinik, Klinikum rechts der Isar	Munich
Germany	Deutsches Herzzentrum	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 rest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic restenosis		6 months	No
Secondary	The combined incidence of death and myocardial infarction as well as target vessel revascularization		one year	No