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

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ClinicalTrials.gov Identifier: NCT01632878
Recruitment Status : Completed
First Posted : July 3, 2012
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Collaborators:
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)
Enrollment 1531
Recruitment Details 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 268 patients screened but not treated with Omacor on physician decision as per the protocol. Consequently 1263 entered in Omacor 1 year treatment assessment
Arm/Group Title Post Myocardial Infarction
Hide Arm/Group Description One single cohort of Index post Myocardial Infarction patients
Period Title: Screening
Started 1531
Completed 1263
Not Completed 268
Reason Not Completed
Physician Decision             268
Period Title: Treatment
Started 1263
Completed 1105
Not Completed 158
Reason Not Completed
Lost to Follow-up             41
Withdrawal by Subject             36
Physician Decision             34
missing information             4
no information on study completion             43
Arm/Group Title Post Myocardial Infarction Omacor Group Post Myocardial Infarction Non-Omacor Group Total
Hide Arm/Group Description Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician Total of all reporting groups
Overall Number of Baseline Participants 1263 268 1531
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1263 participants 268 participants 1531 participants
59.1  (10.64) 59.6  (11.37) 59.2  (10.77)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1263 participants 268 participants 1531 participants
male 948 203 1151
female 311 61 372
unknown 4 4 8
1.Primary Outcome
Title Number of Occurrences of Cardio-vascular Events
Hide Description Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post Myocardial Infarction
Hide Arm/Group Description:
Index post Myocardial Infarction patients (Omacor group)
Overall Number of Participants Analyzed 1263
Measure Type: Number
Unit of Measure: events
Death 4
HF (Heart failure) 3
Recurrent, non-fatal myocardial infarction (RNFMI) 4
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Post Myocardial Infarction
Hide Arm/Group Description Index post Myocardial Infarction patients (Omacor group)
All-Cause Mortality
Post Myocardial Infarction
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Post Myocardial Infarction
Affected / at Risk (%)
Total   43/1263 (3.40%) 
Cardiac disorders   
Angina unstable  1  9/1263 (0.71%) 
Atrial fibrillation  1  5/1263 (0.40%) 
Coronary artery disease  1  2/1263 (0.16%) 
Angina pectoris  1  2/1263 (0.16%) 
Myocardial infarction  1  4/1263 (0.32%) 
Atrioventricular block  1  1/1263 (0.08%) 
Atrial flutter  1  2/1263 (0.16%) 
Atrioventricular block first degree  1  1/1263 (0.08%) 
Bundle branch block left  1  1/1263 (0.08%) 
Cardiac failure  1  2/1263 (0.16%) 
Cardiac failure congestive  1  2/1263 (0.16%) 
Myocardial fibrosis  1  1/1263 (0.08%) 
Postinfarction angina  1  1/1263 (0.08%) 
Ventricular tachycardia  1  1/1263 (0.08%) 
General disorders   
Sudden cardiac death  1  1/1263 (0.08%) 
Sudden death  1  2/1263 (0.16%) 
Hepatobiliary disorders   
Cholecystitis acute  1  1/1263 (0.08%) 
Infections and infestations   
Pneumonia  1  2/1263 (0.16%) 
Injury, poisoning and procedural complications   
Coronary artery restenosis  1  1/1263 (0.08%) 
Foreign body  1  1/1263 (0.08%) 
Post procedural haemorrhage  1  1/1263 (0.08%) 
Investigations   
Alanine aminotransferase increased  1  1/1263 (0.08%) 
Aspartate aminotransferase increased  1  1/1263 (0.08%) 
Hepatic enzyme increased  1  1/1263 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Small cell lung cancer stage unspecified  1  1/1263 (0.08%) 
Nervous system disorders   
Loss of consciousness  1  1/1263 (0.08%) 
Syncope  1  1/1263 (0.08%) 
Renal and urinary disorders   
Haematuria  1  1/1263 (0.08%) 
Respiratory, thoracic and mediastinal disorders   
Asphyxia  1  1/1263 (0.08%) 
Pulmonary oedema  1  1/1263 (0.08%) 
Skin and subcutaneous tissue disorders   
Eczema  1  1/1263 (0.08%) 
Haemorrhage subcutaneous  1  1/1263 (0.08%) 
Vascular disorders   
Hypotension  1  1/1263 (0.08%) 
Aortic arteriosclerosis  1  1/1263 (0.08%) 
Arteriosclerosis  1  1/1263 (0.08%) 
Hypertension  1  1/1263 (0.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Post Myocardial Infarction
Affected / at Risk (%)
Total   0/0 
Adverse Events (non-serious) were not monitored in this observational study. This explains why 0/0 was reported
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.
ClinicalTrials.gov 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