ovel strategies of antithrombotic prophylaxis in patients with Essential Thrombocythemia (ET) at high risk of cardiovascular events: comparison of different dosing regimens of administration of low-dose acetylsalicylic acid - ARES-Aspirin Regimens in ESsential thrombocythemia

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 300 人开始时间: 2020年11月4日最近更新: 2022年3月14日

试验速览

暂无简介。

•A patient will be eligible if all of the following criteria apply:
•- age between 18 and 75 years;
•- an ET diagnosis according to WHO 2008 criteria;2
•- ongoing aspirin 100 mg daily since at least 1 month, according to the judgement of the referring Hematologist;
•- the patient understands and voluntarily signs an informed consent.
•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 240
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•A patient is not eligible if any of the following criteria apply:
•- platelet count >1,000,000/µL on three occasions over the 2 months before enrolment;
•- creatinine level >1.5 x upper limit of normal;
•- liver disease defined as AST and/or ALT values >3 x upper limit of normal;
•- BMI >35 kg/m2;
•- history of major bleeding that in the referring Hematologist's judgement may expose the patient to increased risk of bleeding recurrence
•- active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas;
•- pregnancy or lactation;
•- use of non-steroidal anti-inflammatory drugs (NSAIDs) >3 times/week;
•- use of antiplatelet agents other than aspirin 100 mg od;
•- use of oral anticoagulants including vitamin K antagonists, anti-Xa or -IIa agents;
•- use of heparins or fondaparinux
•- chronic use of steroids (prednisone >5 mg/die or equivalent)

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE