International Study using Clopidogrel and Aspirin for the treatment of Polycythemia Vera.

INTERVENTION: 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 INN or Proposed INN: ACETYLSALICYLIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Polycythemia Vera ; MedDRA version: 9.1 Level: LLT Classification code 10036057 Term: Polycythaemia vera PRIMARY OUTCOME: 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. Primary end point(s): nd Secondary Objective: a) to assess the role of cytochrome P450 2C19 loss‐of‐function polymorphism in influencing the variability of platelet response to clopidogrel ; 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