ISRCTN40976937已完成不适用
A multicentre, randomised, double-blind, placebo controlled trial to evaluate the efficacy of pravastatin for the prevention of vascular events in the elderly
Bristol-Myers Squibb Company (USA)0 个研究点目标入组 5,500 人开始时间: 2013年6月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males or females
- •2. Aged 70-82 years
- •3. As diagnosed by the primary care physician, evidence of vascular disease including stable angina or intermittent claudication or stroke, transient ischaemic attack (TIA), myocardial infarction (MI), arterial surgery, or amputation for vascular disease more than 6 months prior to study entry
- •4. No evidence of previous vascular disease as stated above, but considered to be at high risk for vascular disease on the basis of:
- •4.1. Current smoking status
- •4.2. Hypertension, currently receiving drug treatment
- •4.3. Known diabetes mellitus
- •4.4. Total cholesterol 4.0 - 9.0 mmol/
排除标准
- •1. Recent stroke, TIA, MI, arterial surgery, or amputation for vascular disease less than 6 months prior to study entry
- •2. Any surgery requiring overnight hospitalisation (including angioplasty) less than 6 months prior to study entry
- •3. Poor cognitive function at baseline (Mini Mental Status Examination Score [MMSE] < 24)
- •4. Physically or mentally unable to attend the clinic for the screening visit
- •5. Cholesterol: Total cholesterol (TC < 4.0 mmol/L or TC > 9.0 mmol/L), Triglycerides (TG > 6.0 mmol/L)
- •6. Severe renal impairment (serum creatinine > 200 µmol/L)
- •7. Significant liver disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 X upper limit of normal for the laboratory)
- •8. History of malignancy within the past 5 years except localised basal cell carcinoma of the skin
- •9. Congestive heart failure (New York Heart Association Functional Class III or IV)
- •10. ECG evidence of atrial fibrillation, atrial flutter, or other significant arrhythmia, or Wolff-Parkinson-White Syndrome (WPW)
- •11. Significant untreated thyroid disease
- •12. Organ transplant recipient
- •13. Current lipid-lowering treatment
- •14. Previous participation in a clinical trial using an HMG CoA reductase inhibitor
- •15. Inability to give informed consent
- •16. Planned long-term travel or emigration within next 3 years
- •17. Current alcohol or drug abuse
- •18. Co-habitation with another trial participant
- •19. Less than 75% or greater than 120% compliance with placebo lead-in medication
- •20. Receipt of any investigational drugs (including placebo) within 30 days of enrolment
- •21. Inability to tolerate oral medication or a history of significant malabsorption
- •22. Any other medical condition which renders the patient unable to complete the study which would interfere with optimal participation in the study or produce significant risk to the patient
- •Abnormal laboratory findings include:
- •1. Hemoglobin < 11 g/dl
- •2. Hematocrit < 33%
- •3. Platelet count < 100,000/mm³
- •4. White blood cell count < 3,500/mm³ or > 15,000/mm³
- •5. Serum creatinine > 200 µmol/L
- •6. Potassium < 3.0 mmol/L or 5.0 mmol/L
- •7. Sodium < 130 mmol/L or 150 > mmol/L
- •8. Aspartate aminotransferase/alanine aminotransferase (AST or ALT) > 3.0 X upper limit of normal for the laboratory
- •9. Creatine kinase (CK) > 3 times upper limit of normal for the laboratory
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