A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012269-71-DE

Enrollment

7000

Registered

2009-12-08

Start date

2010-03-08

Completion date

Unknown

Last updated

2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes patients with a recent acute coronary syndrome (ACS) event MedDRA version: 14.1 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Aleglitazar Product Code: RO0728804 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Aleglitazar CAS Number: 475479-34-6 Current Sponsor code: RO0728804 Concentration unit: µ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults >18 years of age Type 2 diabetes mellitus Hospitalization for ACS event and randomization 2-6 weeks after day of hospitalization 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 4700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2300

Exclusion criteria

Exclusion criteria: Estimated glomerular filtration rate 400 mg/dL Anaemia Symptomatic congestive heart failure classified as NYHA class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether aleglitazar reduces cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction (MI) 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 • To evaluate the effects of aleglitazar on glycemic control, the lipoprotein profile, blood pressure, and biomarkers of cardiovascular risk. • To evaluate the tolerability and long-term safety profile of aleglitazar (with special attention to known PPAR class adverse events such as fluid retention, heart failure, fractures, renal function, musculoskeletal adverse events and liver enzyme elevation).;Primary end point(s): - Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke - Effects on other cardiovascular endpoints;Timepoint(s) of evaluation of this end point: Throughout study, approximately 4.5 years	—

Measure

Time frame

Main Objective: To determine whether aleglitazar reduces cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction (MI) 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 • To evaluate the effects of aleglitazar on glycemic control, the lipoprotein profile, blood pressure, and biomarkers of cardiovascular risk. • To evaluate the tolerability and long-term safety profile of aleglitazar (with special attention to known PPAR class adverse events such as fluid retention, heart failure, fractures, renal function, musculoskeletal adverse events and liver enzyme elevation).;Primary end point(s): - Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke - Effects on other cardiovascular endpoints;Timepoint(s) of evaluation of this end point: Throughout study, approximately 4.5 years

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk 2. Tolerability and long-term safety profile ;Timepoint(s) of evaluation of this end point: For 1: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter For 2: Throughout study, approximately 4.5 years	—

Countries

Australia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, India, Ireland, Italy, Malaysia, New Zealand, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026