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
Results First Received: December 22, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Myocardial Infarction (MI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1531 patients were screened and the decision to treat patients with Omacor was made by the treating physician. 268 patients were not treated with Omacor according to the protocol. Only baseline characteristics were reported without any further follow-up for these patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
268 patients screened but not treated with Omacor on physician decision as per the protocol. Consequently 1263 entered in Omacor 1 year treatment assessment

Reporting Groups
  Description
Post Myocardial Infarction One single cohort of Index post Myocardial Infarction patients

Participant Flow for 2 periods

Period 1:   Screening
    Post Myocardial Infarction  
STARTED     1531  
COMPLETED     1263  
NOT COMPLETED     268  
Physician Decision                 268  

Period 2:   Treatment
    Post Myocardial Infarction  
STARTED     1263  
COMPLETED     1105  
NOT COMPLETED     158  
Lost to Follow-up                 41  
Withdrawal by Subject                 36  
Physician Decision                 34  
missing information                 4  
no information on study completion                 43  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Post Myocardial Infarction Omacor Group Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician
Post Myocardial Infarction Non-Omacor Group Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
Total Total of all reporting groups

Baseline Measures
    Post Myocardial Infarction Omacor Group     Post Myocardial Infarction Non-Omacor Group     Total  
Number of Participants  
[units: participants]
  1263     268     1531  
Age  
[units: years]
Mean (Standard Deviation)
  59.1  (10.64)     59.6  (11.37)     59.2  (10.77)  
Gender, Customized  
[units: participants]
     
male     948     203     1151  
female     311     61     372  
unknown     4     4     8  



  Outcome Measures

1.  Primary:   Number of Occurrences of Cardio-vascular Events   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Adverse Events (non-serious) were not monitored in this observational study. This explains why 0/0 was reported


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Patrick Aubonnet / Medical Director
Organization: Mylan
e-mail: patrick.aubonnet@mylan.com



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
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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