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

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2008年11月11日最近更新: 2012年9月3日

适应症

试验速览

暂无简介。

•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

• 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

发起方

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI