Trial Outcomes & Findings for Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study (NCT NCT01632878)
NCT ID: NCT01632878
Last Updated: 2022-03-31
Results Overview
Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)
Recruitment status
COMPLETED
Target enrollment
1531 participants
Primary outcome timeframe
12 months
Results posted on
2022-03-31
Participant Flow
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.
268 patients screened but not treated with Omacor on physician decision as per the protocol. Consequently 1263 entered in Omacor 1 year treatment assessment
Participant milestones
| Measure |
Post Myocardial Infarction
One single cohort of Index post Myocardial Infarction patients
|
|---|---|
|
Screening
STARTED
|
1531
|
|
Screening
COMPLETED
|
1263
|
|
Screening
NOT COMPLETED
|
268
|
|
Treatment
STARTED
|
1263
|
|
Treatment
COMPLETED
|
1105
|
|
Treatment
NOT COMPLETED
|
158
|
Reasons for withdrawal
| Measure |
Post Myocardial Infarction
One single cohort of Index post Myocardial Infarction patients
|
|---|---|
|
Screening
Physician Decision
|
268
|
|
Treatment
Lost to Follow-up
|
41
|
|
Treatment
Withdrawal by Subject
|
36
|
|
Treatment
Physician Decision
|
34
|
|
Treatment
missing information
|
4
|
|
Treatment
no information on study completion
|
43
|
Baseline Characteristics
Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study
Baseline characteristics by cohort
| Measure |
Post Myocardial Infarction Omacor Group
n=1263 Participants
Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician
|
Post Myocardial Infarction Non-Omacor Group
n=268 Participants
Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
|
Total
n=1531 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 10.64 • n=39 Participants
|
59.6 years
STANDARD_DEVIATION 11.37 • n=41 Participants
|
59.2 years
STANDARD_DEVIATION 10.77 • n=35 Participants
|
|
Sex/Gender, Customized
male
|
948 participants
n=39 Participants
|
203 participants
n=41 Participants
|
1151 participants
n=35 Participants
|
|
Sex/Gender, Customized
female
|
311 participants
n=39 Participants
|
61 participants
n=41 Participants
|
372 participants
n=35 Participants
|
|
Sex/Gender, Customized
unknown
|
4 participants
n=39 Participants
|
4 participants
n=41 Participants
|
8 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSuch as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)
Outcome measures
| Measure |
Post Myocardial Infarction
n=1263 Participants
Index post Myocardial Infarction patients (Omacor group)
|
|---|---|
|
Number of Occurrences of Cardio-vascular Events
Death
|
4 events
|
|
Number of Occurrences of Cardio-vascular Events
HF (Heart failure)
|
3 events
|
|
Number of Occurrences of Cardio-vascular Events
Recurrent, non-fatal myocardial infarction (RNFMI)
|
4 events
|
Adverse Events
Post Myocardial Infarction
Serious events: 43 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Post Myocardial Infarction
n=1263 participants at risk
Index post Myocardial Infarction patients (Omacor group)
|
|---|---|
|
Cardiac disorders
Angina unstable
|
0.71%
9/1263 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
5/1263 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.16%
2/1263 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.16%
2/1263 • 1 year
|
|
Nervous system disorders
Loss of consciousness
|
0.08%
1/1263 • 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.08%
1/1263 • 1 year
|
|
Vascular disorders
Hypotension
|
0.08%
1/1263 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.16%
2/1263 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.32%
4/1263 • 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.08%
1/1263 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.16%
2/1263 • 1 year
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.08%
1/1263 • 1 year
|
|
Cardiac disorders
Bundle branch block left
|
0.08%
1/1263 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.16%
2/1263 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.16%
2/1263 • 1 year
|
|
Cardiac disorders
Myocardial fibrosis
|
0.08%
1/1263 • 1 year
|
|
Cardiac disorders
Postinfarction angina
|
0.08%
1/1263 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.08%
1/1263 • 1 year
|
|
General disorders
Sudden cardiac death
|
0.08%
1/1263 • 1 year
|
|
General disorders
Sudden death
|
0.16%
2/1263 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
1/1263 • 1 year
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.08%
1/1263 • 1 year
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.08%
1/1263 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.08%
1/1263 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.08%
1/1263 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.08%
1/1263 • 1 year
|
|
Investigations
Hepatic enzyme increased
|
0.08%
1/1263 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.08%
1/1263 • 1 year
|
|
Nervous system disorders
Syncope
|
0.08%
1/1263 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.08%
1/1263 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.08%
1/1263 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.08%
1/1263 • 1 year
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.08%
1/1263 • 1 year
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.08%
1/1263 • 1 year
|
|
Vascular disorders
Arteriosclerosis
|
0.08%
1/1263 • 1 year
|
|
Vascular disorders
Hypertension
|
0.08%
1/1263 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place