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

Conditions
Polycythemia Vera
MedDRA version: 9.1Level: LLTClassification code 10036057Term: Polycythaemia vera
Registration Number
EUCTR2007-007801-63-IT
Lead Sponsor
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
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

 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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: a) to determine whether clopidogrel is effective in reducing leukocyte activation existing in popcythemic patients; <br>b )to rule out a major increase of the bleeding risk due in patients treated with the combination therapy; and <br>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
Secondary Outcome Measures
NameTimeMethod
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