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
- Conditions
- Patients with T2D and a recent ACS event.MedDRA version: 12.1Level: LLTClassification code 10007649Term: Cardiovascular disorder
- Registration Number
- EUCTR2009-012269-71-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6000
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method