Text Size

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

This study is currently recruiting participants.
Verified June 2013 by Abbott
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01632878
First received: June 29, 2012
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  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:

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

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)


Estimated Enrollment: 4000
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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

  • Males and females 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632878

Contacts
Contact: Jean-Pascal Berrou 0041(0)61 487 0457 jean-pascal.berrou@abbott.com
Contact: Cem Arkilic +41(0)61 487 0350 cem.arkilic@abbott.com

Locations
Bulgaria
Site Reference ID/Investigator# 81558 Recruiting
Plovdiv, Bulgaria, 4003
Principal Investigator: Site Reference ID/Investigator# 81558            
Sponsors and Collaborators
Abbott
Investigators
Study Director: Cem Arkilic 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: June 12, 2013
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 June 18, 2013