Oral Sirolimus for In-Stent Restenosis

A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Impact of Oral Sirolimus on Restenosis Prevention in Patients With In-Stent Restenosis.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00859183

Acronym

OSIRIS

Enrollment

300

Registered

2009-03-10

Start date

2001-10-31

Completion date

2004-03-31

Last updated

2009-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Restenosis

Keywords

in-stent restenosis, stents, sirolimus

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.

Interventions

DRUGSirolimus

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

DRUGPlacebo

Placebo oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Angiographic restenosis	6 months

Secondary

Measure	Time frame
The combined incidence of death and myocardial infarction as well as target vessel revascularization	one year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026