ACTRN12616000535471已完成3 期
Effect of long term pravastatin treatment on mortality due to coronary heart disease in patients who have suffered a recent acute myocardial infarction or have a diagnosis of unstable angina pectoris.
HMRC Clinical Trials Centre, The University of Sydney0 个研究点目标入组 9,000 人开始时间: 2016年4月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 31 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. ENTRY DIAGNOSIS:
- •A.Patients who have suffered an acute myocardial infarction in the period three months to three years prior to screening, where acute myocardial infarction satisfies the following criteria:
- •1)Discharge diagnosis of acute myocardial infarction in hospital records, OR
- •2)Any 2 of the following 3:
- •a.History of typical ischaemic pain lasting for at least 15 minutes and unresponsive to sublingual nitrates
- •b.Elevation of CK enzymes to more than twice the upper limit of normal
- •c.Development of new Q-Waves and/or evolutionary ST-T wave changes lasting at least one day.
- •B.Patients who have been discharged from hospital with a diagnosis of unstable angina pectoris three months to three years prior to assessment, where unstable angina pectoris is defined as definite ischaemic pain increasing in frequency and duration, and/or angina occurring at rest.
- •2. SERUM CHOLESTEROL:
- •Total cholesterol between 4.0 and 7.0 mmol/L, measured by the Central Lipid Laboratory in the 4 weeks prior to randomisation
排除标准
- •1. Patients who are unlikely to be available for the duration of follow-up:
- •i)patients with life threatening illnesses other than coronary artery disease, who are not expected to survive for six years (such as organ transplants), or
- •ii)those who are unreliable including those with known drug or alcohol related problems.
- •2. Any cardiac surgery, angioplasty, major surgery or major illness within the past three months.
- •3. Severely compromised cardiac function (whether due to ischaemic heart disease or not), manifest by either:
- •i)New York Heart Association (NYHA) Class III or IV congestive heart failure (at the time of assessment).
- •ii)Left ventricular ejection fraction less than 25% (if measured).
- •4. History of cerebrovascular disease, including completed stroke or transient ischaemic attack within three months.
- •5. Significant renal or hepatic disease (such as serum creatinine > 160 micromol/L, serum albumin <3.0 g/dl; bilirubin >30 micromol/L, serum ALT or AST >1.5x the upper limit of normal).
- •6. Any uncontrolled endocrine disease (particularly if likely to require hospitalisation); chronic pancreatitis; dysproteinaemia; porphyria; systemic lupus erythematosus.
- •7. Treatment with :
- •(a) other lipid-lowering agents;
- •(b) cyclosporin;
- •(c) other investigational drugs.
- •8. Known hypersensitivity to HMG-CoA reductase inhibitors or serious adverse reactions from prior administration of HMG-CoA reductase inhibitors.
- •9. Significant gastrointestinal disease or surgery which might interfere with drug absorption.
- •10. Women of child-bearing potential (ie pre-menopausal, unless surgically sterilised) and lactating women.
- •11. Fasting triglyceride (as measured by the Central Lipid Laboratory) of greater than 5mmol/L
研究者
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