Oral Sirolimus for In-Stent Restenosis

Phase 4

Completed

• Conditions: Coronary Restenosis
• Interventions: Drug: Placebo; Drug: Sirolimus

• Registration Number: NCT00859183
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2004-02
• Study Completion: 2004-03
• Status Verified: 2009-03
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-09
• Last Update Submitted: 2009-03-09
• Study First Posted: 2009-03-10
• Last Update Posted: 2009-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	oral placebo
1	Sirolimus	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
2	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

Primary Outcome Measures

Name	Time	Method
Angiographic restenosis	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Medizinische Klinik I, Garmisch-Partenkirchen; 🇩🇪 Garmisch-Partenkirchen, Germany

1. Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Deutsches Herzzentrum; 🇩🇪 Munich, Germany