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
- Acuut coronair syndroom1002859310018424
- Registration Number
- NL-OMON36231
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 150
1. Males or females aged > 18 years
2. Known T2D/ established T2D (confirmed prior to randomization according to the diagnostic criteria section 4.4)
3. Hospitalization for an ACS event and randomization between hospital discharge and 8 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 when the patient's conditions are deemed stable by the investigator but no later than 8 weeks from this new event. However, for 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
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, chloeastasis, 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 at randomization
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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The time to first occurrence of any component of the composite endpoint of<br /><br>cardiovascular mortality, non-fatal myocardial infarction and non-fatal stroke.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to first occurrence of:<br /><br>- a composite with the following components: cardiovascular mortality, nonfatal<br /><br>MI, hospitalization for biomarker-negative ACS, and non-fatal stroke<br /><br>- a composite with the following components: all cause mortality, non-fatal MI<br /><br>and non-fatal stroke<br /><br>- individual components of the composite endpoints:<br /><br>- unanticipated coronary revascularization, ie excluding planned before<br /><br>randomization </p><br>