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

NCT01718288 | Completed Phase 4 DMC

• 1 other identifier: Eudract Number: 2006-001660-23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 14

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

Conditions

Peripheral Arterial Disease

Keywords

PAD; iloprost; walking distance; cardiovascular events

Outcome Measures

Primary Outcomes (1)

• Measure of PFWD(pain-free walking distance)in patients with 2b stage PAD

  Aim of this multicenter, randomized, controlled study was prospectively evaluate the effects of iloprost, added to standard therapy, in patients with 2b stage PAD and PFWD (pain-free walking distance) less than 100 metres, eligible and non-eligible for surgical revascularization. A treadmill test 3-6-9-12 months (before iloprost cycle for patients group 1B and 2B). A final evaluation 13 months (for one month to the conclusion of the 12 months treatment of iloprost for patients group 1B and 2B, and after 13 months from enrolling for patients in the study group 1A and 2A)

  13 months

Secondary Outcomes (3)

• Assessing changes in endurance

  13 months

• The possible occurrence of major complications

  13 months

• Quality of life

  13 months

Study Arms (4)

iloprost + standard treat.(aspirin)

EXPERIMENTAL

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

Drug: iloprost; Drug: Standard Treatment (aspirin.....),

Standard Treatment (aspirin....)

ACTIVE COMPARATOR

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

Drug: Standard Treatment (aspirin.....),

Vascular surgery patients + iloprost

EXPERIMENTAL

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

Drug: iloprost; Drug: Standard Treatment (aspirin.....),

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

ACTIVE COMPARATOR

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

Drug: Standard Treatment (aspirin.....),

Interventions

iloprost 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

Also known as: ENDOPROST*0,05MG/0,5ML 1F

Vascular surgery patients + iloprost; iloprost + standard treat.(aspirin)

Standard Treatment (aspirin.....), 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

Also known as: aspirin, antiplatelet, statins,hemorheological/vasodilators

Standard Treatment (aspirin....); Vasc. Surg.+ standard treat. (aspirin..); Vascular surgery patients + iloprost; iloprost + standard treat.(aspirin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Fadoi Foundation, Italy: lead

Study Sites (14)

Angiology, Hospital "G. Fucito"

Mercato San Severino, Salerno, 84085, Italy

Location

Internal Medicine, Hospital "Policlinico"

Bari, 70124, Italy

Location

Angiology, Hospital "Ferrarotto - Alessi"

Catania, 95100, Italy

Location

Internal Medicine, Hospital "Pugliese - Ciaccio"

Catanzaro, 88100, Italy

Location

Internal Medicine, Hospital of Fermo

Fermo, 63900, Italy

Location

Vascular Surgery, Hospital "Galliera"

Genoa, 16128, Italy

Location

Internal Medicine, Hospital Civile

Legnano, 20025, Italy

Location

Internal Medicine, "Madonna delle Grazie" Hospital

Matera, 75100, Italy

Location

Internal Medicine, Hospital "Fatebenefratelli"

Naples, 80123, Italy

Location

Surgery Dept., Hospital " San Giovanni Bosco"

Naples, 80144, Italy

Location

Internal Medicine, Hospital "Bianchi Melacrino Morelli"

Reggio Calabria, 89100, Italy

Location

Internal Medicine, Hospital Policlinico Campus Biomedico

Rome, 00155, Italy

Location

Internal Medicine, Hospital "Fondazione Circolo Macchi"

Varese, 21100, Italy

Location

Internal Medicine, Hospital "Jazzolino"

Vibo Valentia, 89900, Italy

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Iloprost; Aspirin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Gualberto Gussoni, MD, PhD

  Fadoi Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 31, 2012
• Study Start: November 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2012
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

IT (14)