ISRCTN41829447已完成未知
TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis
niversity of Manchester (UK)0 个研究点目标入组 3,002 人开始时间: 2006年7月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 3,002
研究概览
简要总结
2015 results in: http://rheumatology.oxfordjournals.org/content/54/suppl_1/i87.1.extract 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30983166 (added 06/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 30/04/2008:
- •1. Patients must satisfy the 1987 ACR criteria for rheumatoid arthritis applied cumulatively
- •2. Patients must be aged more than 50 or have had RA disease duration for more than 10 years
- •3. Patients must provide their written informed consent
- •Previous inclusion criteria:
- •1. Patients must satisfy the 1987 ACR criteria for rheumatoid arthritis applied cumulatively
- •2. Patients must be 40 years or older
- •3. Patients must provide their written informed consent
排除标准
- •Current exclusion criteria as of 30/04/2008:
- •1. Patients who are pregnant or women of child-bearing age not using adequate contraception
- •2. Known primary muscle disorder
- •3. Known atherosclerotic disease
- •4. Known familial hyperlipidamia requiring drug therapy
- •5. Known diabetes
- •6. Known hypersensitivity or intolerance to statins
- •7. Active liver disease or hepatic dysfunction with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than two times Upper Limit of Normal (ULN)
- •8. Severe renal dysfunction (creatinine >150 micromol/l)
- •9. Creatinine phosphokinase (CK) more than three times ULN
- •10. Uncontrolled hypothyroidism (defined as any elevation of Thyroid-Stimulating Hormone [TSH] above ULN)
- •11. Participation in another clinical trial concurrently or within 30 days prior to screening for entry into this study (patients may be participating in an observational study such as the British Society for Rheumatology Biologics register)
- •12. Other serious illness or significant abnormalities that may compromise the patient's safety or successul participation in the study
- •13. Any illness which, in the doctor's opinion, means that the patient is unable to give informed consent
- •14. Known alcohol abuse
- •Previous exclusion criteria:
- •1. Patients who are pregnant or women of child-bearing age not using adequate contraception
- •2. Known primary muscle disorder
- •3. Known atherosclerotic disease
- •4. Known familial hyperlipidamia requiring drug therapy
- •5. Known diabetes
- •6. Calculated absolute ten year Cardio-Vascular Disease (CVD) risk of 20% or higher, using the Joint British Societies revised risk calculator
- •7. Known hypersensitivity or intolerance to statins
- •8. Active liver disease or hepatic dysfunction with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than two times Upper Limit of Normal (ULN)
- •9. Severe renal dysfunction (creatinine >150 micromol/l)
- •10. Creatinine phosphokinase (CK) more than three times ULN
- •11. Uncontrolled hypothyroidism (defined as any elevation of Thyroid-Stimulating Hormone [TSH] above ULN)
- •12. Participation in another clinical trial concurrently or within 30 days prior to screening for entry into this study (patients may be participating in an observational study such as the British Society for Rheumatology Biologics register)
- •13. Other serious illness or significant abnormalities that may compromise the patient's safety or successul participation in the study
- •14. Any illness which, in the doctor's opinion, means that the patient is unable to give informed consent
- •15. Known alcohol abuse
研究者
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TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RARheumatoid arthritis is associated with increased mortality from cardiovascular disease (CVD). Statins have a proven effect in reducing CVD events in at-risk populations, mostly due to their cholesterol-lowering properties, but possibly through anti-inflammatory and immunomodulatory effects. This trial will assess the hypothesis that atorvastatin is more effective than placebo in the primary prevention of cardiovascular events in patients with RA.EUCTR2006-006032-22-GBniversity of Manchester5,350
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