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

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. Identifier: NCT01632878
Recruitment Status : Completed
First Posted : July 3, 2012
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
inVentiv Health Germany GmbH
EBC - Evidence Based Communication
Information provided by (Responsible Party):
Mylan Inc.

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Myocardial Infarction (MI)

  Participant Flow

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
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 
Physician Decision                268 

Period 2:   Treatment
    Post Myocardial Infarction
STARTED   1263 
Lost to Follow-up                41 
Withdrawal by Subject                36 
Physician Decision                34 
missing information                4 
no information on study completion                43 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 1263   268   1531 
[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

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

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

Responsible Party: Mylan Inc. 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