A Phase 4 interventional study of Sirolimus and Sirolimus in Coronary Restenosis, sponsored by Deutsches Herzzentrum Muenchen. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-10.
Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Treatment
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.
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.
97 studies on the registry are indexed under Coronary Restenosis; 9 are open to participants now.
This study's enrollment of 300 is above the median of 240 across 59 interventional studies indexed under Coronary Restenosis.
Browse Coronary Restenosis studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
oral placebo
Drug: Placebo
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
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
Also known as: Rapamune
Placebo oral
Angiographic restenosis
Time frame: 6 months
The combined incidence of death and myocardial infarction as well as target vessel revascularization
Time frame: one year
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Deutsches Herzzentrum Muenchen