Rationale and methodology of the I.C.A.I. study, a randomised clinical trial of alprostadil in the treatment of chronic critical leg ischemia

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Abstract

Objective: to evaluate the safety and efficacy of a stable prostaglandin E1 added to the usual therapeutic practice (either invasive or not) in patients with chronic critical leg ischemia. Design: multicenter, controlled, randomised, open label trial. Setting: a representative sample (56 centers) of vascular and general surgery, angiology and general medicine departments of the Italian National Health Service. Patients: all patients suffering from leg ischemia considered as chronic anti critical depending on the presence of persistently recurring rest pain for more than two weeks and/or foot ulceration or gangrene. Intervention: a daily i.v. infusion of 60 μg of alprostadil α-cyclodextrine for the overall hospital stay, up to a maximum of 28 days (as an adjunct to the standard procedures adopted in each center) to patients randomly assigned in the experimental treatment. Measures: the primary evaluation of efficacy is based on the expected reduction of major amputations or persistence of critical leg ischemia at six months. The sum of these 'peripheral' events, of death and of non-fatal myocardial infarction and stroke is used as a more comprehensive evaluation of the risk/benefit profile of the experimental treatment. Results: a reduction from 40% to 32% of the incidence of the primary end-points is the trial hypothesis. The recruitment of 1500 patients is required to verify this. Conclusions: this large-scale trial aims at providing a reliable estimate of the possibility of modifying hard endpoints such an death and amputation in patients with critical leg ischemia.

Original languageEnglish
Pages (from-to)93-98
Number of pages6
JournalJournal of Nephrology
Volume9
Issue number2
Publication statusPublished - Mar 1 1996

Fingerprint

Alprostadil
Leg
Ischemia
Randomized Controlled Trials
Amputation
Therapeutics
Gangrene
National Health Programs
Cardiology
Patient Selection
Blood Vessels
Foot
Length of Stay
Stroke
Myocardial Infarction
Medicine
Safety
Pain
Incidence

Keywords

  • Critical leg ischemia
  • Prostanoids
  • Randomised clinical trial
  • Trial methodology

ASJC Scopus subject areas

  • Nephrology

Cite this

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title = "Rationale and methodology of the I.C.A.I. study, a randomised clinical trial of alprostadil in the treatment of chronic critical leg ischemia",
abstract = "Objective: to evaluate the safety and efficacy of a stable prostaglandin E1 added to the usual therapeutic practice (either invasive or not) in patients with chronic critical leg ischemia. Design: multicenter, controlled, randomised, open label trial. Setting: a representative sample (56 centers) of vascular and general surgery, angiology and general medicine departments of the Italian National Health Service. Patients: all patients suffering from leg ischemia considered as chronic anti critical depending on the presence of persistently recurring rest pain for more than two weeks and/or foot ulceration or gangrene. Intervention: a daily i.v. infusion of 60 μg of alprostadil α-cyclodextrine for the overall hospital stay, up to a maximum of 28 days (as an adjunct to the standard procedures adopted in each center) to patients randomly assigned in the experimental treatment. Measures: the primary evaluation of efficacy is based on the expected reduction of major amputations or persistence of critical leg ischemia at six months. The sum of these 'peripheral' events, of death and of non-fatal myocardial infarction and stroke is used as a more comprehensive evaluation of the risk/benefit profile of the experimental treatment. Results: a reduction from 40{\%} to 32{\%} of the incidence of the primary end-points is the trial hypothesis. The recruitment of 1500 patients is required to verify this. Conclusions: this large-scale trial aims at providing a reliable estimate of the possibility of modifying hard endpoints such an death and amputation in patients with critical leg ischemia.",
keywords = "Critical leg ischemia, Prostanoids, Randomised clinical trial, Trial methodology",
author = "Vittorio Bertele and Roncaglioni, {Maria Carla} and Gianni Tognoni",
year = "1996",
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T1 - Rationale and methodology of the I.C.A.I. study, a randomised clinical trial of alprostadil in the treatment of chronic critical leg ischemia

AU - Bertele, Vittorio

AU - Roncaglioni, Maria Carla

AU - Tognoni, Gianni

PY - 1996/3/1

Y1 - 1996/3/1

N2 - Objective: to evaluate the safety and efficacy of a stable prostaglandin E1 added to the usual therapeutic practice (either invasive or not) in patients with chronic critical leg ischemia. Design: multicenter, controlled, randomised, open label trial. Setting: a representative sample (56 centers) of vascular and general surgery, angiology and general medicine departments of the Italian National Health Service. Patients: all patients suffering from leg ischemia considered as chronic anti critical depending on the presence of persistently recurring rest pain for more than two weeks and/or foot ulceration or gangrene. Intervention: a daily i.v. infusion of 60 μg of alprostadil α-cyclodextrine for the overall hospital stay, up to a maximum of 28 days (as an adjunct to the standard procedures adopted in each center) to patients randomly assigned in the experimental treatment. Measures: the primary evaluation of efficacy is based on the expected reduction of major amputations or persistence of critical leg ischemia at six months. The sum of these 'peripheral' events, of death and of non-fatal myocardial infarction and stroke is used as a more comprehensive evaluation of the risk/benefit profile of the experimental treatment. Results: a reduction from 40% to 32% of the incidence of the primary end-points is the trial hypothesis. The recruitment of 1500 patients is required to verify this. Conclusions: this large-scale trial aims at providing a reliable estimate of the possibility of modifying hard endpoints such an death and amputation in patients with critical leg ischemia.

AB - Objective: to evaluate the safety and efficacy of a stable prostaglandin E1 added to the usual therapeutic practice (either invasive or not) in patients with chronic critical leg ischemia. Design: multicenter, controlled, randomised, open label trial. Setting: a representative sample (56 centers) of vascular and general surgery, angiology and general medicine departments of the Italian National Health Service. Patients: all patients suffering from leg ischemia considered as chronic anti critical depending on the presence of persistently recurring rest pain for more than two weeks and/or foot ulceration or gangrene. Intervention: a daily i.v. infusion of 60 μg of alprostadil α-cyclodextrine for the overall hospital stay, up to a maximum of 28 days (as an adjunct to the standard procedures adopted in each center) to patients randomly assigned in the experimental treatment. Measures: the primary evaluation of efficacy is based on the expected reduction of major amputations or persistence of critical leg ischemia at six months. The sum of these 'peripheral' events, of death and of non-fatal myocardial infarction and stroke is used as a more comprehensive evaluation of the risk/benefit profile of the experimental treatment. Results: a reduction from 40% to 32% of the incidence of the primary end-points is the trial hypothesis. The recruitment of 1500 patients is required to verify this. Conclusions: this large-scale trial aims at providing a reliable estimate of the possibility of modifying hard endpoints such an death and amputation in patients with critical leg ischemia.

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