CTRI/2014/01/004269已完成4 期
To evaluate the efficacy and safety of intensive dose of rosuvastatin, 40 mg/day, initiated early and continued for 12 weeks, in â??very highâ?? risk or â??highâ?? risk patients, according to NCEP ATP III guidelines, in Indian patients.
Ranbaxy Laboratories Ltd0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •i.Adult patients (30 to 69 years of age) with evidence of coronary artery disease, who are hospitalized with recent chest pain (ischemic symptoms) with or without ECG changes.
- •ii.Patients with non-ST segment elevation ACS and ST segment elevation ACS who received optimal reperfusion therapy are eligible.
排除标准
- •i.Patients with LDL-C level 70 mg/dL (Very High Risk) and 100 mg/dL (High Risk)
- •ii.Receiving intensive lipid-lowering therapy of Rosuvastatin 40 mg for 3 months before admission
- •iii.Active liver disease or dysfunction indicated by levels of alanine aminotransferase (ALT) 3 Ã? upper limit of normal (ULN)
- •iv.Unexplained serum creatine kinase (CK) level 3 Ã? ULN;
- •v.Serum creatinine 2.0 mg/dL;
- •vi.History of hypersensitivity to statins
- •vii.Pregnant and lactating women
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