EUCTR2006-003119-35-AT进行中（未招募）不适用
Effects of simvastatin in patients after cardioversion (SIPAC) of non valvular atrial fibrillation - The AF Prophylaxis Trial
Medical University of Vienna, Department of Clinical Pharmacology0 个研究点目标入组 60 人开始时间: 2006年10月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •-Age>18yrs
- •-At least second episode of non valvular, persistent, symptomatic AF within one year, defined by an echocardiogram asserting non valvular origin and a duration of at least 12 hours.
- •-Patient willing to undergo cardioversion if no spontaneous conversion to sinus
- •rhythm occurs within 12 hours
- •-Written informed consent
- •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
- •-First episode of AF
- •-Last episode longer than a year ago
- •-Termination within 12 hours
- •-Transient atrial fibrillation caused by known reversible disorders (thyrotoxicosis, alcohol intoxication etc.)
- •-Known refractoriness to cardioversion (after several trials, permanent AF)
- •-Severe valvular heart disease
- •-Current atrial myxoma or left ventricular thrombus
- •-Left Ventricular Ejection Fraction < 30%
- •-Severe rhythmological disorders other than AF (WPW-Syndrome, AV block II-III etc)
- •- Prolonged QT interval (QTc interval of >500ms)
- •-Stroke within the previous 30 days or transient ischaemic attack within 3 days
- •-Treatment with fibrinolytic agents within 30 days before randomisation
- •-History of intracranial, intraocular, spinal, retroperitoneal, overt gastrointestinal or atraumatic intra-articular bleeding during the last year
- •-Endoscopically verified ulcer disease in the previous 30 days
- •-Major surgical procedure or trauma in the previous 30 days
- •-Planned major surgery
- •-Haemorrhagic disorder
- •-Admission for acute coronary syndrome or percutaneous coronary intervention within 30 days
- •-Persistent blood pressure 180/100 mm Hg or greater with or without antihypertensive treatment
- •-Need for regular use of non-steroidal anti-inflammatory at anti-inflammatory doses
- •-Renal insufficiency (calculated creatinine clearance <30 mL/min)
- •-Creatinine level of more than 2.5 mg per deciliter
- •-Known severe hepatic disorders or persistent elevation of liver enzymes of more than two times the upper limit of normal
- •-Unexplained elevation in the creatine kinase level more than three times the upper limit of normal
- •-Women with child bearing potential
- •-Drug addiction, alcohol abuse
- •-Anaemia (haemoglobin <100 g/L or platelet count <100x109/L)
- •-Abnormal electrolytes despite adequate therapy (especially potassium <3.5 or >5 mmol/L)
- •-Estimated life expectancy <2 years
- •-Already receiving statin therapy and need for statin therapy
- •-Explicit need for statin therapy: Persons with established CHD or CHD risk equivalent (i.e. PAD or diabetes mellitus), who have a baseline LDL cholesterol =130 mg/dL
- •-Known hypersensitivity to statins
- •-Lipid-lowering therapy with fibric acid derivatives or niacin that cannot be discontinued before randomization,
- •-Drugs that are strong inhibitors of cytochrome P-450 3A4 within the month before randomization or patients likely to require such treatment during the study period (because simvastatin is metabolized by this pathway)
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