CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,531 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01632878
NCT01632878N/ACompleted

Omacor Plus Standard Therapies In Post MI Subjects Evaluation: The OPTIMISE Study

Mylan Inc.·observational·Posted Jul 3, 2012·Updated Mar 31, 2022

In Brief

An observational study for Myocardial Infarction (MI). Completed, enrolled 1,531 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 3, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.0 years ago