EUCTR2007-001723-36-DK进行中（未招募）不适用
A controlled, randomized, parallel, multi-centre, feasibility study of the oral direct thrombin inhibitor AZD0837, given as extended-release formulation, in the prevention of stroke and systemic embolic events in patients with atrial fibrillation, who are appropriate for but unable or unwilling to take Vitamin-K antagonist therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Signed informed consent given by the patient before any study-specific procedures are initiated
- •Paroxysmal, persistent or permanent NVAF verified by at least 2 ECGsa in the last year separated by at least one weekb; for:
- •- Newly diagnosed patients: the second ECG should be carried out within the 2 weeks prior to randomization
- •- Other patients: the second ECG should be carried out within the 12 weeks prior to randomization
- •aClarification:
- •ECG verification can be done by 12 lead ECG, 24 hour Holter monitoring or event recording of good quality, but not via pacemaker. Thus, paroxysmal AF can be defined by 2 or more episodes of AF (lasting >30 seconds) on a single 24 hour Holter performed within 3 months of randomisation.
- •bClarification:
- •In 'high risk' AF patients not on VKA treatment, the one week gap between the 1st and 2nd ECGs [which should still be on separate days] is not mandatory, if local clinical practice requires initiation of antithrombotic therapy as soon as possible. The second ECG should still be carried out within the 2 weeks prior to randomisation.
- •In addition to AF the patient must have the following risk factors
- •Either one of the following risk factors is sufficient for inclusion (high risk patient):
- •- Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30 days prior to randomization)
- •- Previous systemic embolism
- •or at least one of the following risk factors are needed for inclusion (1 risk factor = moderate risk patient, 2 or more risk factors = high risk patient):
- •- Age =75 years
- •- Symptomatic congestive heart failure
- •- Impaired left ventricular systolic function
- •- Diabetes mellitus
- •- Hypertension requiring anti-hypertensive treatmentc
- •cHypertensive patients who are enrolled and randomized into the study should be well controlled and have antihypertensive treatment aiming for a blood pressure <160/100 mmHg.
- •In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy by fulfilling at least one of the following criteria
- •- In hospital records, documented inability to keep International normalized ration (INR) levels within 2.0 to 3.0 during a continuous and recent period of at least 3 months, leading to the conclusion that VKA therapy does not offer an adequate level of benefit vs. risk, in the specific patientd, e.
- •- Permanent cessation or refusalf by the patient to take VKA therapy due to reasons specified in hospital records present, recorded no later than one month before start of the study.
- •- Refusal to participate in study D1250C00008 due to the possibility of being randomized to VKA treatmentd. For VKA naïve patients this must have been stated in the hospital records at least 1 week in advance of enrolment in the study.
- •- Treating physician’s assessment that VKA is inappropriate for this patient recorded no later than one month before start of this studyd.
- •- Allergic reactions to VKA as documented in hospital recordsf.
- •dReason must be stated in the hospital records and in the pCRF.
- •eINR must be <2 at randomization.
- •fReason must be stated in the pCRF.
- •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 randomization
- •Weight <50 kg at enrolment
- •Lactation; child-bearing potential, ie, women must be either post-menopausal, permanently sterilised or, if of child-bearing potential, must have a negative pregnancy test prior to initiation of study drug and use a reliable form of contraception before and during participation in the study.
- •- Post menopausal patients are defined as patients with: natural or induced menopause with last menstruation >1 year ago or bilateral oophorectomy.
- •- Reliable 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).
- •Atrial fibrillation secondary to reversible disorders, eg, hyperthyroidism, drugs and pulmonary embolism
- •Presence of a clinically significant valvular heart disease, as well as 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) or percutaneous transluminal coronary angioplasty within the previous 3 months prior to randomization
- •Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
- •Conditions associated with increased risk of major bleeding for example:
- •- High risk of falling accident
- •- High bleeding risk, exceeding possible benefit of the antithrombotic treatment
- •- History of intracranial bleeding
- •- History of bleeding gastrointestinal disorder and/or endoscopically verified ulcer disease within the last year prior to randomization
- •- Major surgical procedure or trauma 2 weeks prior to randomization
- •Diastolic blood pressure >100 mmHg or systolic blood pressure >180 mmHg with or without antihypertensive treatment
- •Renal impairment (calculated creatinine clearance <30 ml/min)
- •Known hepatic disease and/or ALAT >3 x ULN
- •History or presence of infectious hepatitis (including known HbSAg positive or antibodies against Hepatitis C) or human immunodeficiency virus (HIV)
- •Known Gilbert’s syndrome
- •Anemia (Hb<100g/L = 6.2 mmol/L)
- •Platelet count <100 x109/L
- •Treatment with antiplatelet other than ASA or fibrinolytic agents within 10 days before randomization
- •Planned cardioversion or surgery during the study
- •Other serious disease that gives a calculated survival less than 12 months or any condition making a patient too frail to participate in the study
- •Known drug addiction or alcohol abuse
- •Inability to complete the study according to the protocol
- •Previous enrolment or randomization of treatment in the present study. Participating in any other clinical study within 4 weeks (in UK within 12 weeks) prior to enrolment
- •Treatment with AZD0837 in previous or ongoing AZD0837 study(ies)
- •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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