EUCTR2008-003698-42-ES进行中（未招募）不适用
Estudio Fase III, multicéntrico, aleatorizado , de grupos paralelos, doble ciego, doble enmascarado, controlado, para evaluar la eficacia y seguridad del inhibidor directo oral de la trombina AZD0837 comparado con Warfarina en la prevención del ictus y de acontecimientos embólicos sistémicos en pacientes con fibrilación auricular (ASSURE-AF)A controlled, randomised, double-blind, double-dummy, parallel-group, phase III, multicenter study to evaluate efficacy and safety of the oral direct thrombin inhibitor AZD0837 compared to warfarin for the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (ASSURE-AF) - ASSURE-AF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14,600
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
- •1. Provision of informed consent prior to any study specific procedures
- •2. Female or male aged =18 years
- •3. Rhythm verification
- •Patient with paroxysmal AF: Clinically significant 5 paroxysmal AF with at least one
- •documented episode of AF 6 within 12 months. The AF can be documented by 12-
- •lead electrocardiogram (ECG), Holter, event recorder or telemetry, but not by
- •pacemaker. OR
- •Patient with permanent or persistent AF 5 : AF documented on two occasions >7 days
- •apart within 12 months. The AF can be documented by 12-lead ECG, Holter, event
- •recorder or telemetry, but not by pacemaker.
- •4. Stroke risk classification:
- •At least one of the following risk factors:
- •Prior ischaemic stroke, TIA 7 and/or systemic embolism
- •Patient aged =75 years
- •Alternatively at least two of the following risk factors if neither of the risk factors
- •Hypertension 8
- •Symptomatic CHF and/or left ventricular ejection fraction (LVEF) =35%
- •Diabetes mellitus
- •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
- •1. Women of childbearing potential without a reliable form of contraception, as judged
- •by the Investigator, before and during participation in the study
- •2. Lactation
- •3. AF secondary to a current reversible disorder, (eg, hyperthyroidism, isolated
- •postoperative AF, drugs and pulmonary embolism)
- •4. Allergic and/or intolerant to VKA
- •5. Valvular heart disease if
- •Any mitral valve prosthesis, or
- •Mechanical valve prosthesis, or
- •Mitral stenosis, or
- •Any other valvular heart disease considered to significantly increase the risk of
- •thromboembolic events or considered hemodynamically significant or expected to
- •require surgical intervention during the course of the study
- •6. Active infective endocarditis
- •7. Any condition other than AF requiring chronic anticoagulation treatment
- •8. Myocardial Infarction (MI), heart surgery (eg, coronary artery bypass grafting,
- •CABG) and/or percutaneous coronary intervention (PCI) within the 3 months prior
- •to enrolment. Any prior PCI requiring clopidogrel treatment at the time of
- •9. Stroke, TIA and/or systemic embolism within the previous 14 days prior to
- •randomisation
- •10. Known haemorrhagic disorders and/or conditions associated with increased risk of
- •major bleeding
- •11. Severe renal impairment (calculated creatinine clearance (CrCL) <30 mL/min)
- •12. Known hepatic disease and/or ALT >3xULN and/or bilirubin >2xULN
- •13. Uncontrolled hypertension, systolic blood pressure =180 mmHg
- •14. Anemia (Hb<100g/L = 6.2 mmol/L) and/or platelet count <100x10 9 /L
- •15. Planned pulmonary vein ablation procedure, PCI or major surgery. Planned
- •cardioversion (direct current (DC) or pharmacological) within 1 month of
- •randomisation.
- •16. Other serious disease that gives an estimated survival less than 12 months, any
- •condition making a patient too frail to participate in the study, and/or inability to
- •complete the study according to the protocol. Severe neurological deficit or
- •disability that would interfere with the detection and/or assessment of a new
- •cerebrovascular event.
- •17. Known drug addiction and/or alcohol abuse
- •18. Previous enrolment or randomisation of treatment in the present study and/or
- •participation in a previous study with AZD0837
- •19. Participation in another clinical study with IP and/or intervention during the last
- •20. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site)
研究者
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