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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:
ClinicalTrials.gov Identifier:
NCT01632878
First Posted: July 3, 2012
Last Update Posted: May 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
inVentiv Health Germany GmbH
EBC - Evidence Based Communication
Information provided by (Responsible Party):
Mylan Inc.
  Purpose
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
Myocardial Infarction (MI)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Omacor Plus Standard Therapies In Post MI Subjects Evaluation: The OPTIMISE Study

Resource links provided by NLM:


Further study details as provided by Mylan Inc.:

Primary Outcome Measures:
  • 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)


Enrollment: 1531
Study Start Date: July 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post Myocardial Infarction
One single cohort of Index post Myocardial Infarction patients

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT01632878     History of Changes
Other Study ID Numbers: P13-764
First Submitted: June 29, 2012
First Posted: July 3, 2012
Results First Submitted: December 22, 2015
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