EUCTR2007-001722-27-SE进行中（未招募）不适用
ong-term treatment with the oral direct thrombin inhibitor AZD0837, compared to Vitamin-K antagonists, as stroke prevention in patients with non-valvular atrial fibrillation and one or more risk factors for stroke and systemic embolic events. A 5-year follow-up study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •Provision of informed consent
- •Patients who fulfilled the inclusion criteria in study D1250C00008 and completed the planned study treatment period in study D1250C00008 without safety concerns regarding continued treatment, as assessed by the investigator
- •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
排除标准
- •Aged <18 years at inclusion
- •Weight <40 kg at enrolment
- •Childbearing potential, ie women must be either post-menopausal a, permanently sterilized or, if of childbearing potential, must have a negative pregnancy test prior to initiation of study drug and use a reliable form of contraception b before and during the participation in the study. Women must not be breast feeding
- •aPost menopausal patients are defined as patients with natural or induced menopause with last menstruation >1 year ago or bilateral oophorectomy
- •bReliable form of contraception is defined as: oral contraceptive, implant, long term injectable contraceptive, intrauterine device or tubal ligation. However, female patients using hormonal anti-conception method (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional barrier method for contraception (condom or diaphragm)
- •AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
- •Known contraindication to VKA treatment
- •Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
- •Myocardial infarction, heart surgery (eg coronary artery bypass graft, CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the previous three months prior to inclusion
- •Stroke and/or systemic embolism within the previous 30 days prior to inclusion
- •Conditions associated with increased risk of major bleeding for example:
- •-history of intracranial bleeding
- •-history of bleeding gastrointestinal disorder and/or endoscopically verified ulcer disease within the last year prior to inclusion
- •-major surgical procedure or trauma two weeks prior to inclusion
- •Diastolic blood pressure (DBP) >100 mmHg or systolic blood pressure (SBP) >180 mmHg with or without antihypertensive treatment
- •Renal impairment (calculated creatinine clearance <30 ml/min) at the time of enrolment
- •Known hepatic disease and/or ALAT >3xULN at enrolment
- •History or presence of Human Immunodeficiency Virus (HIV) or infectious hepatitis including known HbSAg positive or antibodies against Hepatitis C
- •Known Gilberts syndrome
- •Anaemia (Hb<100 g/L = 6.2 mmol/L)
- •Platelet count <100 x 109/L
- •Treatment with antiplatelet other than ASA =100 mg/day or fibrinolytic agents within 10 days before inclusion
- •Planned (at the time of enrolment) cardioversion or surgery during the study
- •Other serious disease that give a calculated survival less than 12 months or any condition making a patient too frail to participate in the study
- •Known drug addiction and/or alcohol abuse
- •Inability to complete the study according to the protocol
- •Previous enrolment or inclusion of treatment in the present study. Participating in any other clinical study, except study D1250C00008, within 4 weeks (in UK within 12 weeks) prior to enrolment
- •Treatment with AZD0837 in previous or ongoing AZD0837 study, except study D1250C00008
- •Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
研究者
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