A clinical trial to study reduction of cardiovascular mortality and morbidity in Type 2 diabetes mellitus patients with a recent Acutecoronarysyndrome event
- Registration Number
- CTRI/2010/091/000516
- Lead Sponsor
- The George Institute for international Health-India839C, Road No:44A, Jubilee Hills,Hyderabad-500033Andhra Pradesh- India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6000
1.Males or females aged > 18 years
2. Known Type 2 Diabetes or newly diagnosed Type2Diabetes (confirmed prior to randomization according to the American Diabetes Association diagnostic criteria
3. Hospitalization for an ACS event 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
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 beforerandomization 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 The primary endpoint of this study is the time to first occurrence of any component of the composite endpoint as adjudicated by the clinical events Committee. Components of the primary endpoint are cardiovasculardeath, nin-fatal myocardial infarction and non-fatal stroke.Timepoint: The study is an event-driven trial and will last until 950<br>adjudicated events occur but at least until all patients are<br>treated for 2.5 years.<br>
- Secondary Outcome Measures
Name Time Method A composite with the following components: cardiovascular mortality, non-fatal MI, hospitalization for biomarker-negative ACS and non-fatal stroke <br><br>A composite with the following components: all-cause mortality, non-fatal MI and non-fatal stroke <br><br>Individual components of the composite endpoints <br><br>Unanticipated, ie, excluding planned before randomization, coronary revascularization <br>Timepoint: The study is an event-driven trial and will last until 950<br>adjudicated events occur but at least until all patients are<br>treated for 2.5 years.<br>