NCT00859183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2001

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
Last Updated

March 10, 2009

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

March 6, 2009

Last Update Submit

March 9, 2009

Conditions

Coronary Restenosis

Keywords

in-stent restenosisstentssirolimus

Outcome Measures

Primary Outcomes (1)

  • Angiographic restenosis

    6 months

Secondary Outcomes (1)

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

    one year

Study Arms (3)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

3

PLACEBO COMPARATOR

oral placebo

Drug: Placebo

Interventions

SirolimusDRUG

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

Also known as: Rapamune
1
PlaceboDRUG

Placebo oral

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medizinische Klinik I, Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany

Location

Deutsches Herzzentrum

Munich, 80636, Germany

Location

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (2)

  • 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.

    PMID: 15302787RESULT

  • 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.

    PMID: 19926058DERIVED

MeSH Terms

Conditions

Coronary Restenosis

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Coronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Adnan Kastrati, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

  • Albert Schömig, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 10, 2009

Study Start

October 1, 2001

Primary Completion

February 1, 2004

Study Completion

March 1, 2004

Last Updated

March 10, 2009

Record last verified: 2009-03

Locations

DE(3)