EUCTR2014-004049-29-GB进行中（未招募）1 期
Investigating Aspirin and Ticagrelor for the prevention of tumour cell-induced platelet aggregation - Ticagrelor for prevention of tumour cell-induced platelet aggregation
niversity of Leicester0 个研究点目标入组 300 人开始时间: 2015年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •Healthy Volunteers
- •Provision of informed consent prior to any study specific procedures
- •Male or female aged 18-85
- •Adequate level of spoken and written English to give informed consent
- •Use of 2 types of contraception for duration of involvement
- •Check of TOPS reveals no over-volunteering
- •Use of appropriate contraceptive measures
- •Cardiovascular patients
- •Provision of informed consent prior to any study specific procedures
- •Male or female aged 18-85
- •Adequate level of spoken and written English to give informed consent
- •Use of appropriate contraceptive measures
- •Generic cancer patients – for blood sampling only
- •Provision of informed consent prior to any study specific procedures
- •Male or female aged 18-85
- •Any metastatic solid tumour
- •Adequate level of spoken and written English to give informed consent
- •Breast Cancer patients
- •Provision of informed consent prior to any study specific procedures
- •Female aged 18-85
- •WHO performance status 0-2
- •Presence of metastases in at least one organ/system eg. Liver, lungs, lymphadenopathy.
- •Haematological and biochemical indices within the ranges shown below:
- •Haemoglobin (Hb) =10g/dl,
- •Neutrophils =2000/µl,
- •Platelet count = 100.000/µl and =500,000/ µl,
- •AST or ALT = 3 ULN, alkaline phosphatase = 2x ULN,
- •Serum Bilirubin = 1.5 ULN,
- •Creatinine Clearance = 45ml/min
- •Adequate level of spoken and written English to give informed consent
- •Use of 2 types of contraception for duration of involvement
- •Use of appropriate contraceptive measures
- •Colorectal Cancer patients
- •Provision of informed consent prior to any study specific procedures
- •Male or female aged 18-85
- •Who performance status 0-2
- •Presence of metastases in at least one organ/system eg. Liver, lungs, lymphadenopathy.
- •Haematological and biochemical indices within the ranges shown below:
- •Haemoglobin (Hb) =10g/dl,
- •Neutrophils = 2000/µl,
- •Platelet count = 100.000/µl and =500,000/ µl,
- •AST or ALT = 3 ULN, alkaline phosphatase = 2x ULN,
- •Serum Bilirubin = 1.5 ULN,
- •Creatinine Clearance = 45ml/min
- •Adequate level of spoken and written English to give informed consent
- •Use of 2 types of contraception for duration of involvement
- •Use of appropriate contraceptive measures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •Previous history of intracranial bleed
- •Any pre-existent bleeding disorder
- •History of gastrointestinal bleeding requiring transfusion in the last year or peptic ulceration in the last year
- •Current prescription of any antiplatelet therapy for another clinical indication
- •Current anticoagulation
- •Currently receiving cytotoxic chemotherapy
- •Currently receiving tamoxifen (other endocrine therapies are allowed)
- •More than 3 lines of chemotherapy for metastatic disease
- •Current treatment with NSAIDS
- •Current or long term use of oral corticosteroids
- •Previous history of aspirin or Ticagrelor intolerance.
- •Pregnancy or breast feeding
- •History of other malignancy less than 5 years before the diagnosis of breast or colorectal cancer, EXCLUDING the following: Non-melanoma skin cancer, in situ carcinoma of the cervix treated surgically with curative intent, other malignant tumours that have been treated curatively and patient is deemed disease-free
- •Any other physical condition which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including patients with a high risk of mortality from another cause within the trial treatment period.
- •Inadequate level of spoken and written English to give informed consent
- •Pregnancy / trying to get pregnant. Pregnancy is an absolute dicontinuation criteria.
- •Use of strong CYP 3A4 inhibiting medicines including Boceprevir,Clarithromycin,Cobicistat,HIV-protease inhibitors boosted with ritonavir,nefazodone, atazanavir, Itraconazole,Ketoconazole,Nelfinavir,Ritonavir,Saquinavir,Telaprevir,Telithromycin,
- •Voriconazole
- •Patients with gout
研究者
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