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Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb) (2bPILOT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fadoi Foundation, Italy
ClinicalTrials.gov Identifier:
NCT01718288
First received: October 22, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Peripheral Arterial Disease
Drug: iloprost
Drug: Standard Treatment (aspirin.....),
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb), Unsuitable or Suitable to Surgical Revascularization / Endovascular With Reference to the Change of Pain-free Walking Distance and Other Endpoints

Resource links provided by NLM:


Further study details as provided by Fadoi Foundation, Italy:

Primary Outcome Measures:
  • Measure of PFWD(pain-free walking distance)in patients with 2b stage PAD [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Assessing changes in endurance [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    A clinical evaluation 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)

  • The possible occurrence of major complications [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    The study reported the number of events during all the study (13 months). The major complication were: Ischemic cardiopathy, critical limb ischemia, cerebrovascular event, critical limb ischemia

  • Quality of life [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    For the Quality of life, the study used a specific questionnaire administrated to all patients enrolled in the study (13 months of observation): IQOLA (International Quality of Life Assessment),SF-36 Italian Version 1.6


Enrollment: 150
Study Start Date: November 2006
Study Completion Date: April 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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

Other Name: ENDOPROST*0,05MG/0,5ML 1F
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

Other Name: aspirin, antiplatelet, statins,hemorheological/vasodilators
Active Comparator: 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

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

Other Name: aspirin, antiplatelet, statins,hemorheological/vasodilators
Experimental: 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
Drug: 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

Other Name: ENDOPROST*0,05MG/0,5ML 1F
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

Other Name: aspirin, antiplatelet, statins,hemorheological/vasodilators
Active Comparator: Vasc. Surg.+ standard treat. (aspirin..)
2A - patients suitable to vascular surgical or endovascular therapy + standard treatment (aspirin...)
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

Other Name: aspirin, antiplatelet, statins,hemorheological/vasodilators

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".

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718288

Locations
Italy
Angiology, Hospital "G. Fucito"
Mercato San Severino, Salerno, Italy, 84085
Internal Medicine, Hospital "Policlinico"
Bari, Italy, 70124
Angiology, Hospital "Ferrarotto - Alessi"
Catania, Italy, 95100
Internal Medicine, Hospital "Pugliese - Ciaccio"
Catanzaro, Italy, 88100
Internal Medicine, Hospital of Fermo
Fermo, Italy, 63900
Vascular Surgery, Hospital "Galliera"
Genoa, Italy, 16128
Internal Medicine, Hospital Civile
Legnano, Italy, 20025
Internal Medicine, "Madonna delle Grazie" Hospital
Matera, Italy, 75100
Internal Medicine, Hospital "Fatebenefratelli"
Naples, Italy, 80123
Surgery Dept., Hospital " San Giovanni Bosco"
Naples, Italy, 80144
Internal Medicine, Hospital "Bianchi Melacrino Morelli"
Reggio Calabria, Italy, 89100
Internal Medicine, Hospital Policlinico Campus Biomedico
Rome, Italy, 00155
Internal Medicine, Hospital "Fondazione Circolo Macchi"
Varese, Italy, 21100
Internal Medicine, Hospital "Jazzolino"
Vibo Valentia, Italy, 89900
Sponsors and Collaborators
Fadoi Foundation, Italy
Investigators
Study Director: Gualberto Gussoni, MD, PhD Fadoi Foundation
  More Information

No publications provided

Responsible Party: Fadoi Foundation, Italy
ClinicalTrials.gov Identifier: NCT01718288     History of Changes
Other Study ID Numbers: Eudract Number: 2006-001660-23
Study First Received: October 22, 2012
Last Updated: October 29, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Fadoi Foundation, Italy:
PAD; iloprost; walking distance; cardiovascular events

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases
Aspirin
Dalteparin
Heparin, Low-Molecular-Weight
Iloprost
Vasodilator Agents
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticoagulants
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014