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
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 29, 2012
Results First Received: December 22, 2015
Last Updated: April 4, 2016
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Saudi Arabia: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
Croatia: Ethics Committee
Lithuania: Bioethics Committee
Hungary: Scientific and Medical Research Council Ethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Kuwait: Joint Committee for the Protection of Human Subjects in Research
Bulgaria: Ethics committee
Estonia: Research Ethics Committee
Australia: Human Research Ethics Committee
Thailand: Ethical Committee
Estonia: The State Agency of Medicine
Ireland: Irish Medicines Board
Bulgaria: Ministry of Health
Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on July 26, 2016