Polycythemia Vera MedDRA version: 9.1 Level: LLT Classification code 10036057 Term: Polycythaemia vera
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Clopidogrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: ASPIRINA
Pharmaceutical Form: Tablet
I
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females subjects from 65 up to and including 80 years of age with either a new diagnosis or medical history of PV of less than 5 year duration are eligible for the study if they meet the following inclusion criteria:  High CV risk due to age ≥ 65 years and prior vascular event  No contraindication for aspirin use  Ability and willingness to comply with all study requirements  Written informed consent (obtained before any study specific procedure). 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:  History of major bleeding  Clinical indication for the association aspirin plus clopidogrel and/or for a different antithrombotic regimen  Presence of any life-threatening condition  History of active substance or alcohol abuse within the last year  Known hypersensitivity or contraindication to study treatments  Significant liver disease  Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol  Presence of any disease (e.g. cancer) that is likely to significantly shorten life expectancy  Age> 80 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a) to determine whether clopidogrel is effective in reducing leukocyte activation existing in popcythemic patients; b )to rule out a major increase of the bleeding risk due in patients treated with the combination therapy; and c) to assess the prevalence of clopidogrel resistance in polycythemic subjects.;Secondary Objective: a) to assess the role of cytochrome P450 2C19 loss-of-function polymorphism in influencing the variability of platelet response to clopidogrel ;;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed