Myocardial Infarction (MI) Clinical Trial
Official title:
Omacor Plus Standard Therapies In Post MI Subjects Evaluation: The OPTIMISE Study
| NCT number | NCT01632878 |
| Other study ID # | P13-764 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2012 |
| Est. completion date | December 2014 |
| Verified date | April 2016 |
| Source | Viatris Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1531 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Site Reference ID/Investigator# 81558 | Plovdiv |
| Lead Sponsor | Collaborator |
|---|---|
| Mylan Inc. | EBC - Evidence Based Communication, inVentiv Health Germany GmbH |
Bulgaria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Occurrences of Cardio-vascular Events | Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF) | 12 months |
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