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)

• Conditions: Type 2 diabetes patients with a recent acute coronary syndrome (ACS) event; MedDRA version: 12.0Level: LLTClassification code 10007649Term: Cardiovascular disorder

• Registration Number: EUCTR2009-012269-71-HU
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether aleglitazar reduces cardiovascular mortality and morbidity<br>(defined as non-fatal myocardial infarction and non-fatal stroke) in patients with a recent ACS event and T2D;Secondary Objective: • To evaluate the effects of aleglitazar on other clinical endpoints of cardiovascular risk<br>• To evaluate the effects of aleglitazar on glycemic control, the lipoprotein profile,<br>blood pressure, and biomarkers of cardiovascular risk.<br>• To evaluate the tolerability and long-term safety profile of aleglitazar (with special<br>attention to known PPAR class adverse events such as fluid retention, heart failure,<br>fractures, renal function, musculoskeletal adverse events and liver enzymes<br>elevation).;Primary end point(s): The primary endpoint of this study is the time to first occurrence of any component of the composite event as adjudicated by the CEC. Components of the event are:<br>• Cardiovascular death<br>• Non fatal myocardial infarction<br>• Non-fatal stroke