Clinical Trial: Oral Sirolimus for In-Stent Restenosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Deutsches Herzzentrum Muenchen

Current Primary Outcome: Angiographic restenosis [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The combined incidence of death and myocardial infarction as well as target vessel revascularization [ Time Frame: one year ]

Original Secondary Outcome: Same as current

Information By: Deutsches Herzzentrum Muenchen

Dates:
Date Received: March 6, 2009
Date Started: October 2001
Date Completion:
Last Updated: March 9, 2009
Last Verified: March 2009