N/A
Completed N=1,531
Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study
Myocardial Infarction (MI)
Source: ClinicalTrials.gov NCT01632878 ↗
Enrolled (actual)
1,531
Serious AEs
3.4%
Results posted
May 2016
Primary outcomePrimary: Number of Occurrences of Cardio-vascular Events — 4; 3; 4 events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Occurrences of Cardio-vascular Events |
4; 3; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01632878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.