EUCTR2009-012269-71-IT进行中（未招募）不适用
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). - ALECARDIO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males or females aged > 18 years; 2. Known T2D or newly diagnosed T2D (confirmed prior to randomization according to the American Diabetes Association diagnostic criteria see protocol section 4.4); 3. Hospitalization for an ACS event (see definition below) 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 before randomization 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.
研究者
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