CTRI/2010/091/000516已完成3 期
Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)
The George Institute for international Health-India839C, Road No:44A, Jubilee Hills,Hyderabad-500033Andhra Pradesh- India0 个研究点目标入组 6,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,000
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
入选标准
- •1.Males or females aged > 18 years
- •2. Known Type 2 Diabetes or newly diagnosed Type2Diabetes (confirmed prior to randomization according to the American Diabetes Association diagnostic criteria
- •3. Hospitalization for an ACS event and randomization within 2 to 6 weeks after the ACS index event (day of hospitalization). In case of any subsequent ACS event, procedure related MI or coronary bypass surgery occurring during the run-in period, randomization should occur between 2 and 6 weeks from this event. In these patients, the allowed maximum duration from index event to randomization is 12 weeks.
- •4. Ability and willingness to give written informed consent and to comply with the requirements of the study
排除标准
- •1.Concomitant treatment with a thiazolidinedione and/or fibrate
- •2. Prior intolerance to a thiazolidinedione and/or fibrate
- •3. Triglycerides (fasting) > 400 mg/dL (> 4.5 mmol/L)
- •4. Patients with clinically apparent liver disease, eg, jaundice, choleastasis, hepatic impairment, active hepatitis or asymptomatic ALT > 3x ULN
- •5.Anemia defined as hemoglobin< 10 g/dL (< 100 g/L, 6.21 mmol/L) or hematocrit<30 %
- •6. eGFRMDRD < 45 ml/min/1.73m2
- •7. Symptomatic congestive heart failure classified as NYHA class II-IV
- •8. Hospitalization in the 12-month period preceding the index event for a primary diagnosis of heart failure
- •9. Peripheral edema which in the judgment of the investigator is believed to be clinically severe
- •10. Systemic corticosteroid therapy for > 2 weeks, within 3 months prior to screening examination
- •11. Any serious medical condition that according to the investigator could interfere with the conduct of the study
- •12. Serious comorbid disease in which the life expectancy of the patient is shorter than the duration of the trial (e.g.acute systemic infection, cancer or other serious illnesses).Treated basal-cell carcinoma occurring > 2 years beforerandomization is not excluded
- •13. Unwillingness or inability to comply with study requirements (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
- •14. Positive pregnancy test, breast feeding women or women of childbearing potential not using highly effective methods of contraception
- •15. Participation in any clinical trial with an investigational drug or device within one month prior to the screening
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