Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)

NCT ID: NCT01718288

Last Updated: 2012-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2012-04-30

Brief Summary

Evaluate the possibility of optimization of therapy with prostanoids (iloprost), in patients with Fontaine's stage IIb severe chronic ischemia, both in patients eligible for surgery both in patients for which it is only possible medical therapy

Detailed Description

The management of patients with peripheral arterial disease (PAD) stage IIb and pain-free walking distance (PFWD) less than 100 meters is a major clinical problem, in view of the significant cooling of the quality of life and evolution often severe that characterizes the clinical course of these patients. Revascularization Surgery is the treatment of choice, but about half of patients with severe PAD IIb is not eligible for surgery or endovascular treatment. The usefulness of use of vasodilators or hemorheological is controversial, and medical treatment of these patients is therefore heterogeneous understanding the various pharmacologic options (for the correction of risk factors, prevention of cardiovascular events, improvement of claudication), and rehabilitative programs. Iloprost, a synthetic analogue of prostacyclin, is effective in the treatment of patients with chronic critical ischemia, and its pharmacological profile (effective vasodilator, anti-platelet, and leukocyte activation) is particularly suitable to modulate multiple components pathogenesis of peripheral arterial disease. Specifically, in the treatment of patients with PAD IIb severe, the current state is available only a retrospective study that compared the use of iloprost with that of vasodilators. Aim of the study FADOI-2bPILOT is to evaluate prospectively and for an observation period of 13 months, if you can get a benefit on the pain-free walking distance and on clinical outcome from "anticipated" and additional use of iloprost, in patients with severe IIb stage PAD treated according to current "best medical practice".

Conditions

Peripheral Arterial Disease

Keywords

PAD; iloprost; walking distance; cardiovascular events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iloprost + standard treat.(aspirin)

1B - patients unsuitable to surgical or endovascular vascular therapy: treatment with iloprost intravenous infusions for 10 days every 3 months, in addition to conventional treatment

Group Type: EXPERIMENTAL

iloprost

Intervention Type: DRUG

The study, consists of two substudies, which deal with patients susceptible to medical therapy alone (substudy 1) or treated with classical surgical therapy (substudy 2).

For each substudy, pts will be divided into two groups, one that will receive conventional treatments but not prostanoids, other conventional treatments with addition of iloprost.

The 4 groups:

1A. Pts unsuitable to surgical or endovascular vascular therapy: conventional treatment

1. B. Pts unsuitable to surgical or endovascular vascular therapy: treatment with iloprost plus conventional treatment

2. A. Pts suitable to vascular surgical or endovascular therapy: conventional treatment

2B. Pts suitable to vascular surgical or endovascular therapy: treatment with iloprost plus conventional treatment

Standard Treatment (aspirin.....),

Intervention Type: DRUG

The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.

correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids

Standard Treatment (aspirin....)

1A - patients unsuitable to surgical or endovascular vascular therapy: conventional treatment

Conventional Treatments:correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin / low molecular weight heparin, hemorheological / vasodilators such as pentoxifylline / buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids

Group Type: ACTIVE_COMPARATOR

Standard Treatment (aspirin.....),

Intervention Type: DRUG

The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.

correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids

Vascular surgery patients + iloprost

2B - patients suitable to vascular surgical or endovascular therapy: treatment with intravenous infusions iloprost for 10 days every 3 months, in addition to conventional treatment

Group Type: EXPERIMENTAL

iloprost

Intervention Type: DRUG

The study, consists of two substudies, which deal with patients susceptible to medical therapy alone (substudy 1) or treated with classical surgical therapy (substudy 2).

For each substudy, pts will be divided into two groups, one that will receive conventional treatments but not prostanoids, other conventional treatments with addition of iloprost.

The 4 groups:

1A. Pts unsuitable to surgical or endovascular vascular therapy: conventional treatment

1. B. Pts unsuitable to surgical or endovascular vascular therapy: treatment with iloprost plus conventional treatment

2. A. Pts suitable to vascular surgical or endovascular therapy: conventional treatment

2B. Pts suitable to vascular surgical or endovascular therapy: treatment with iloprost plus conventional treatment

Standard Treatment (aspirin.....),

Intervention Type: DRUG

The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.

correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids

Vasc. Surg.+ standard treat. (aspirin..)

2A - patients suitable to vascular surgical or endovascular therapy + standard treatment (aspirin...)

Group Type: ACTIVE_COMPARATOR

Standard Treatment (aspirin.....),

Intervention Type: DRUG

The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.

correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids

Interventions

iloprost

The study, consists of two substudies, which deal with patients susceptible to medical therapy alone (substudy 1) or treated with classical surgical therapy (substudy 2).

For each substudy, pts will be divided into two groups, one that will receive conventional treatments but not prostanoids, other conventional treatments with addition of iloprost.

The 4 groups:

1A. Pts unsuitable to surgical or endovascular vascular therapy: conventional treatment

1. B. Pts unsuitable to surgical or endovascular vascular therapy: treatment with iloprost plus conventional treatment

2. A. Pts suitable to vascular surgical or endovascular therapy: conventional treatment

2B. Pts suitable to vascular surgical or endovascular therapy: treatment with iloprost plus conventional treatment

Intervention Type: DRUG

Standard Treatment (aspirin.....),

The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.

correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids

Intervention Type: DRUG

Other Intervention Names

ENDOPROST*0,05MG/0,5ML 1F; aspirin, antiplatelet, statins,hemorheological/vasodilators

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: age > 18 years; pain-free walking distance (PFWD) <100 meters on two occasions 10 days apart, with <25% difference between each other; ankle blood pressure (BP) <70 mmHg; big toe BP < 30 mmHg (in case of diabetic patient).

Exclusion Criteria: pain at rest, trophic ulcers or gangrene (critical limb ischemia), if they were unable to cooperate, or one of the following conditions (contraindications or precautions for use of iloprost) was present: myocardial infarction or stroke in the previous 6 months; congestive heart failure NYHA class >II; unstable angina; uncontrolled severe arterial hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg) or hypotension (systolic BP <90 mmHg); hyperkinetic ventricular arrhythmia; acute pulmonary edema or pulmonary congestion; bleeding diathesis; platelet count <80,000 or > 500,000/mm3; renal failure requiring dialysis; liver cirrhosis; pregnancy or breast feeding; history of allergy, hypersensitivity or intolerance to iloprost or other prostanoids.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fadoi Foundation, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gualberto Gussoni, MD, PhD

Role: STUDY_DIRECTOR

Fadoi Foundation

Locations

Angiology, Hospital "G. Fucito"

Mercato San Severino, Salerno, Italy

Internal Medicine, Hospital "Policlinico"

Bari, , Italy

Angiology, Hospital "Ferrarotto - Alessi"

Catania, , Italy

Internal Medicine, Hospital "Pugliese - Ciaccio"

Catanzaro, , Italy

Internal Medicine, Hospital of Fermo

Fermo, , Italy

Vascular Surgery, Hospital "Galliera"

Genoa, , Italy

Internal Medicine, Hospital Civile

Legnano, , Italy

Internal Medicine, "Madonna delle Grazie" Hospital

Matera, , Italy

Internal Medicine, Hospital "Fatebenefratelli"

Naples, , Italy

Surgery Dept., Hospital " San Giovanni Bosco"

Naples, , Italy

Internal Medicine, Hospital "Bianchi Melacrino Morelli"

Reggio Calabria, , Italy

Internal Medicine, Hospital Policlinico Campus Biomedico

Rome, , Italy

Internal Medicine, Hospital "Fondazione Circolo Macchi"

Varese, , Italy

Internal Medicine, Hospital "Jazzolino"

Vibo Valentia, , Italy

Countries

Italy

Other Identifiers

Eudract Number: 2006-001660-23

Identifier Type: -

Identifier Source: org_study_id