Oral Sirolimus for In-Stent Restenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2004-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Sirolimus

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

Sirolimus

Intervention Type DRUG

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

3

oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral

Interventions

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Sirolimus

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

Intervention Type 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

Intervention Type DRUG

Placebo

Placebo oral

Intervention Type DRUG

Other Intervention Names

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Rapamune Rapamune

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No