NCT01632878

Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,531 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction (MI)

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-07-03
• Last updated: 2022-03-31
• Results posted: 2016-05-09

Locations

1 site across 1 country: Bulgaria