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

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ClinicalTrials.gov Identifier: NCT01632878
Recruitment Status : Completed
First Posted : July 3, 2012
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Collaborators:
inVentiv Health Germany GmbH
EBC - Evidence Based Communication
Information provided by (Responsible Party):
Mylan Inc.

Brief 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.

Condition or disease
Myocardial Infarction (MI)

Study Type : Observational
Actual Enrollment : 1531 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Omacor Plus Standard Therapies In Post MI Subjects Evaluation: The OPTIMISE Study
Study Start Date : July 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Group/Cohort
Post Myocardial Infarction
One single cohort of Index post Myocardial Infarction patients



Primary Outcome Measures :
  1. Number of Occurrences of Cardio-vascular Events [ Time Frame: 12 months ]
    Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632878


Locations
Bulgaria
Site Reference ID/Investigator# 81558
Plovdiv, Bulgaria, 4003
Sponsors and Collaborators
Mylan Inc.
inVentiv Health Germany GmbH
EBC - Evidence Based Communication
Investigators
Study Director: Katinka Giezeman Mylan

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT01632878     History of Changes
Other Study ID Numbers: P13-764
First Posted: July 3, 2012    Key Record Dates
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016
Last Verified: April 2016

Keywords provided by Mylan Inc.:
Secondary prevention post MI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases