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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01632878
First received: June 29, 2012
Last updated: July 28, 2014
Last verified: July 2014
  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 Abbott:

Primary Outcome Measures:
  • 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)


Enrollment: 1695
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 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
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, ACE inhibitors/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
Abbott
Investigators
Study Director: Jean-Marc Haeusler Abbott Products Operations AG
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01632878     History of Changes
Other Study ID Numbers: P13-764
Study First Received: June 29, 2012
Last Updated: July 28, 2014
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 Abbott:
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 August 27, 2014