EUCTR2006-006032-22-GB进行中（未招募）1 期
TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RA
niversity of Manchester0 个研究点目标入组 5,350 人开始时间: 2007年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,350
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
入选标准
- •Patients who satisfy 1987 ACR classification criteria for RA applied cumulatively [71]
- •Age =50 years old OR =10 years of RA disease duration
- •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
- •Standard Contra-indications to statin therapy:
- •1)Pregnancy, breast-feeding or women of child-bearing potential not using adequate contraception
- •2)Known atherosclerotic disease i.e. previous episodes of confirmed Acute Coronary Syndrome (ACS), unstable angina; myocardial infarction with or without ST elevation; or stable CHD/CVD deemed to require statin therapy on clinical grounds, including:
- •2a) Previous amputation due to severe peripheral vascular disease or severe peripheral arterial disease
- •2b) Previous central or peripheral revascularisation procedure (including coronary angioplasty, coronary artery bypass graft surgery, peripheral arterial graft surgery)
- •2c) Accelerated hypertension, severe heart failure (class III or IV), significant dysrhythmia or angina requiring hospitalisation in the 6 months preceding potential study entry
- •2d) Uncontrolled hypertension (treated or untreated) defined as systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg (identified as the disappearance of all sound (Korotkoff Phase V) after sitting quietly for at least 3 min)
- •2e) Previous cerebrovascular accident
- •2f) Other accepted indication for statin therapy according to the investigators¡ current clinical practice
- •2g)Known familial hyperlipidaemia requiring drug therapy
- •2h)Known diabetes
- •3a)Known primary muscle disease
- •3b)Known hypersensitivity or intolerance to statins
- •3c)Active liver disease or hepatic dysfunction with AST or ALT >2x upper limit of normal (ULN)
- •3d)Severe renal dysfunction (Creatinine >200 micromol/l)
- •Creatinine phosphokinase (CK) >3xULN
- •3e)Uncontrolled hypothyroidism
- •3f)Taking any of the following medications:
- •i)Other HMG-CoA reductase inhibitors (unless warranted as add-in therapy for post-endpoint management of study patients. In such a case during the course of the trial, it will be suggested to the managing physician to start initially Atorvastatin at a dose of 10mg daily (or equivalent dose of another statin of their choice).
- •ii)Drugs known to be associated with rhabdomyolysis in combination with HMG-CoA reductase inhibitors (e.g. ciclosporin, erythromycin, azo anti-fungals, protease inhibitors and all macrolides)
- •iii)Drugs (other than beta-blockers, diuretics, ACE inhibitors, other anti-hypertensive agents, oral hypoglycaemic agents and thyroxine replacement therapy) known to affect lipid levels, that interact with the study medications, or that may affect clinical laboratory parameters (such as isotretinoin).
- •iv)Lipid-regulating drugs: probucol, fibrates and derivatives, bile acid sequestering resins. Patients currently taking a lipid-altering drug may be considered for screening after a 4-week wash-out period except in the case of probucol where medication must have been discontinued for at least 6 months.
- •v)Drinking more than 1 240ml glass of grapefruit juice per day
- •4)Participation in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
- •5)Other serious illness or significant abnormalities th
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