Acuut coronair syndroom
Conditions
Interventions
Study drug (active or placebo) will be added to a background of
contemporary, evidence-based medical care for ACS and CHD risk
factors, including diabetes.
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to first occurrence of any component of the composite endpoint of cardiovascular mortality, non-fatal myocardial infarction and non-fatal stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of: - a composite with the following components: cardiovascular mortality, nonfatal MI, hospitalization for biomarker-negative ACS, and non-fatal stroke - a composite with the following components: all cause mortality, non-fatal MI and non-fatal stroke - individual components of the composite endpoints: - unanticipated coronary revascularization, ie excluding planned before randomization | — |
Countries
Netherlands
Outcome results
None listed