Myocardial Infarction (MI)
Conditions
Keywords
Secondary prevention post MI
Brief summary
The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection initiative, first compiling data on the current treatment of post myocardial infarction patients (screening-log) and then, prospectively evaluating only those patients being prescribed Omacor as part of their standard secondary prevention treatment. The aim is to observe the Omacor cohort of patients for a period of 12 months, collecting long term observational data as clinical and patient-reported outcomes, especially, but not exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or interventions will be mandated. Only results from routinely performed tests, labs, procedures and/or interventions will be collected if available.
Interventions
None listed
Sponsors
inVentiv Health Germany GmbH
EBC - Evidence Based Communication
Mylan Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients, from the screening-log, having been prescribed prior to their inclusion in the study Omega-3-fatty-acid ethyl esters (Omacor) as adjuvant treatment in secondary prevention after their myocardial infarction, in addition to standard therapy \[e.g. statins, antiplatelet medicinal products, beta blockers, Angiotensine Converting Enzyme (ACE) inhibitors/Angiotensine II Receptor Blockers (ARBs), etc\].
Exclusion criteria
* Omega-3-fatty-acid ethyl esters (Omacor) approved contra-indication as per the labeling information in participating countries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Occurrences of Cardio-vascular Events | 12 months | Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF) |
Countries
Bulgaria
Participant flow
Recruitment details
1531 patients were screened and the decision to treat patients with Omacor was made by the treating physician. 268 patients were not treated with Omacor according to the protocol. Only baseline characteristics were reported without any further follow-up for these patients.
Pre-assignment details
268 patients screened but not treated with Omacor on physician decision as per the protocol. Consequently 1263 entered in Omacor 1 year treatment assessment
Participants by arm
| Arm | Count |
|---|---|
| Post Myocardial Infarction Omacor Group Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician | 1,263 |
| Post Myocardial Infarction Non-Omacor Group Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician | 268 |
| Total | 1,531 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Screening | Physician Decision | 268 |
| Treatment | Lost to Follow-up | 41 |
| Treatment | missing information | 4 |
| Treatment | no information on study completion | 43 |
| Treatment | Physician Decision | 34 |
| Treatment | Withdrawal by Subject | 36 |
Baseline characteristics
| Characteristic | Post Myocardial Infarction Omacor Group | Post Myocardial Infarction Non-Omacor Group | Total |
|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 10.64 | 59.6 years STANDARD_DEVIATION 11.37 | 59.2 years STANDARD_DEVIATION 10.77 |
| Sex/Gender, Customized female | 311 participants | 61 participants | 372 participants |
| Sex/Gender, Customized male | 948 participants | 203 participants | 1151 participants |
| Sex/Gender, Customized unknown | 4 participants | 4 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 43 / 1,263 |
Outcome results
Primary
Number of Occurrences of Cardio-vascular Events
Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post Myocardial Infarction | Number of Occurrences of Cardio-vascular Events | Death | 4 events |
| Post Myocardial Infarction | Number of Occurrences of Cardio-vascular Events | HF (Heart failure) | 3 events |
| Post Myocardial Infarction | Number of Occurrences of Cardio-vascular Events | Recurrent, non-fatal myocardial infarction (RNFMI) | 4 events |