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

This study has been completed.
Sponsor:
Collaborators:
inVentiv Health Germany GmbH
EBC - Evidence Based Communication
Information provided by (Responsible Party):
Mylan Inc.
ClinicalTrials.gov Identifier:
NCT01632878
First received: June 29, 2012
Last updated: April 4, 2016
Last verified: April 2016

June 29, 2012
April 4, 2016
July 2012
December 2014   (final data collection date for primary outcome measure)
Number of Occurrences of Cardio-vascular Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)
Number of Occurrences of Cardio-vascular Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Such as, but not exclusively: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)
Complete list of historical versions of study NCT01632878 on ClinicalTrials.gov Archive Site
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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
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
primary care clinic
Myocardial Infarction (MI)
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Post Myocardial Infarction
One single cohort of Index post Myocardial Infarction patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1531
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria
 
NCT01632878
P13-764
No
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Mylan Inc.
Mylan Inc.
  • inVentiv Health Germany GmbH
  • EBC - Evidence Based Communication
Study Director: Katinka Giezeman Mylan
Mylan Inc.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP