EUCTR2004-000245-38-FR进行中（未招募）1 期
A randomised trial to compare ASPIRIN versus HYDROXYUREA/ASPIRIN in 'intermediate risk' primary thrombocythaemia and ASPIRIN only with observation in 'Low risk' primary thrombocythaemia. - PT1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,459
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •i) The proposal is to include as many patients with PT as possible including previously diagnosed patients whether or not they have received treatment. Thus all patients are eligible assuming they meet the diagnostic criteria and they do not have any exclusion criteria. It will be necessary to stratify patients according to their previous treatment. This information will be collected on entry to the study. Informed consent is of course required where there is a change of therapeutic strategy.
- •- Low risk : Age >or = 18 years and < 40 years with no high risk features (see exclusion criteria).
- •- Intermediate risk : Age 40-59 years with no high risk features (see exclusion criteria).
- •ii) The diagnostic criteria for primary thrombocythaemia are:
- •-1. Platelet count > 600 x 10 E+9 / L.
- •-2.. No evidence of overt polycythaemia (confirmed by RCM if necessary) or of polycythaemia masked by co-existent iron deficiency.
- •-3. No Philadelphia chromosome. .
- •-4.Absence of peripheral blood and/or marrow appearances of myelodysplasia, or myelofibrosis.
- •- No know cause of reactive thrombocytosis. Particular care should be taken to exclude iron deficiency in pre-menopausal women.
- •iii) Written informed consent obtained in accordance with NCRI requirements.
- •iv) Patients with impaired hepatic/renal function are not excluded although the respective biochemical tests should be monitored during therapy and reduced doses of cytoreductive agent should be used, particularly in the case of hydroxyurea and renal dysfunction.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •i) High risk features (any of the following) :
- •* Age > or = 60 years.
- •* Platelet count > or = 1500 x 10 E+9 / L (current or previous).
- •* History of ischaemia, thrombosis or embolic events (including erythromelalgia).
- •* Haemorrhage considered to be related to PT.
- •* Presence of hypertension or diabetes
- •ii) The manufacturers of hydroxyurea state that it should be avoided in pregnancy and in lactating women. Similary, hydroxyurea should not be prescribed for women when there is doubt about their use of an effective contraceptive method.
- •iii) Exclude patient from hydroxyurea therapy and, therefore, from the 'intermediate' risk randomisation if the patient has current leg ulcers.
研究者
相似试验
已完成
不适用
Randomised study to compare aspirin versus hydroxyurea/aspirin in 'intermediate risk' primary thrombocythaemia (PT) and hydroxyurea/aspirin versus anagrelide/aspirin in 'high risk' primary thrombocythaemiaeukaemiaCancerLeukaemiaISRCTN72251782Medical Research Council (MRC) (UK)1,600
招募中
不适用
A cohort study of the performance of ASpirin-FREE therapy after successful percutaneous coronary intervention for acute coronary syndromeDiseases of the circulatory systemKCT0008182Wonkwang University Hospital200
招募中
3 期
Effect of Heparin-Aspirin to prevent thrombosis of knee and hip arthroplastyPulmonary embolismIRCT20170109031845N2Iran University of Medical Sciences100
招募中
3 期
Effectiveness of aspirin and aspririnmetformin combination preventing preeclampsiaPre-eclampsiaIRCT20140317017035N9Shiraz University of Medical Sciences322
进行中（未招募）
不适用
A randomised clinical trial on heparin versus saline solution (NaCl 0,9%) in the maintenance of peripherical venous catheters - NDEUCTR2007-001347-21-ITOSPEDALE POLICLINICO S. MATTEO