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| Name | Class |
|---|---|
| inVentiv Health Germany GmbH | UNKNOWN |
| EBC - Evidence Based Communication | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post Myocardial Infarction | One single cohort of Index post Myocardial Infarction patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Occurrences of Cardio-vascular Events | Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF) | 12 months |
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Inclusion Criteria
Exclusion Criteria
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primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Katinka Giezeman | Mylan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 81558 | Plovdiv | 4003 | Bulgaria |
268 patients screened but not treated with Omacor on physician decision as per the protocol. Consequently 1263 entered in Omacor 1 year treatment assessment
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Post Myocardial Infarction | One single cohort of Index post Myocardial Infarction patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
|
| ||||||||||||||||||
| Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Post Myocardial Infarction Omacor Group | Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician |
| BG001 | Post Myocardial Infarction Non-Omacor Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Occurrences of Cardio-vascular Events | Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF) | Posted | Number | events | 12 months |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post Myocardial Infarction | Index post Myocardial Infarction patients (Omacor group) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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Adverse Events (non-serious) were not monitored in this observational study. This explains why 0/0 was reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Aubonnet / Medical Director | Mylan | patrick.aubonnet@mylan.com |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
|
| 43 |
| 1,263 |
| 0 |
| 0 |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial fibrosis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Postinfarction angina | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Aortic arteriosclerosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |