Patients affected by Systemic Sclerosis with Raynaud’s Phenomenon MedDRA version: 9.1 Level: LLT Classification code 10042953
Conditions
Interventions
Trade Name: PLETAL
Pharmaceutical Form: Tablet
INN or Proposed INN: CILOSTAZOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients suffering from Raynaud’s Phenomenon (mild to severe) and no counter indications for Cilostazol therapy - The study will be conducted on patients affected by Systemic Sclerosis followed in the ambulatory of Immunology of the Department of Internal Medicine - American College of Rheumatology criteria is applied for the diagnosis of Systemic Sclerosis, disease classification (Limited or Diffuse) is determined following LeRoy’s criteria. Disease activity will be evaluated by the EUSTAR Systemic Sclerosis Activity score Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe renal failure: ClCr < 25 ml/min. - Mild to severe hepatic failure. - Congestive heart failure. - Pregnancy and lactation. - Patients with hemorrhagic predisposition (e.g. peptic ulcer, hemorrhagic stroke in the last 3 months, surgical procedures in the last 6 months, diabetic proliferative retinopathy, arterial hypertension not controlled) - Patients assuming CYP3A4 or CYP2C19 inhibitors (e.g. cimetidine, diltiazem, eritromicin, ketoconazole, lansoprazole, omeprazole, HIV-1 protease inhibitors) - Patients with history of ventricular tachycardia, ventricular fibrillation, multifocal ventricular extrasistolia and long QT syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of Cilostazol in reducing the frequency and severity of Raynaud’s Phenomenon attacks in patients affected by Systemic Sclerosis;Secondary Objective: - Evaluate pre- and post-therapy modifications through the evaluation of the FMD (flow-mediated dilation) of the brachial artery - Evaluate in vitro variations of the immunological status (regulatory lymphocytes, effector lymphocytes, pro- and anti-inflammatory cytokines) using immunochemical techniques and flux cytometry;Primary end point(s): Evaluate the efficacy of Cilostazol in reducing the frequency and severity of Raynaud’s Phenomenon attacks in patients affected by Systemic Sclerosis | — |
Countries
Italy
Outcome results
None listed