EUCTR2009-012269-71-HU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)
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 diagnostic criteria in Section 4.4)
- •3. Hospitalization for ACS event (see Section 4.5 for a definition of ACS) and
- •randomization 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. 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. Upcoming revascularization planned to occur after randomization (i.e. percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)). These interventions are allowed to be performed during the screening period/run-in period.
- •2. Concomitant treatment with a thiazolidinedione and/or fibrate
- •3. Prior intolerance to a thiazolidinedione, and/or fibrate
- •4. Triglycerides > 400 mg/dL (> 4.5 mmol/L)
- •5. Patients with clinically apparent liver disease, eg, jaundice, choleastasis, hepatic
- •synthetic impairment, active hepatitis or asymptomatic ALT > 3x ULN
- •6. Anemia defined as hemoglobin < 10 g/dL (< 100 g/L, 6.21 mmol/L) or
- •hematocrit < 30 %
- •7. eGFRMDRD < 45 ml/min/1.73m2 (see Appendix 3 [21])
- •8. Symptomatic congestive heart failure classified as NYHA class II-IV at
- •randomization
- •9. Hospitalization in the 12-month period preceding the index event for a primary
- •diagnosis of heart failure
- •10. Peripheral edema which in the judgment of the investigator is believed to be clinically severe
- •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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