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

NCT01632878 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1531

Last updated 2022-03-31

Study results available
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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)

Sponsors & Collaborators

  • inVentiv Health Germany GmbH

    collaborator UNKNOWN

  • EBC - Evidence Based Communication

    collaborator UNKNOWN

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Katinka Giezeman · Mylan

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632878 on ClinicalTrials.gov