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

NCT01632878 | Completed Results

• 1 other identifier: P13-764
• Study Type: observational
• Target: 1,531
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction (MI)

Keywords

Secondary prevention post MI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Post Myocardial Infarction

One single cohort of Index post Myocardial Infarction patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may not qualify if:

• Omega-3-fatty-acid ethyl esters (Omacor) approved contra-indication as per the labeling information in participating countries

Sponsors & Collaborators

• Mylan Inc.: lead
• inVentiv Health Germany GmbH: collaborator
• EBC - Evidence Based Communication: collaborator

Study Sites (1)

Site Reference ID/Investigator# 81558

Plovdiv, 4003, Bulgaria

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Limitations and Caveats

Adverse Events (non-serious) were not monitored in this observational study. This explains why 0/0 was reported

Results Point of Contact

• Title: Patrick Aubonnet / Medical Director
• Organization: Mylan

patrick.aubonnet@mylan.com

Study Officials

• Katinka Giezeman

  Mylan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 3, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 31, 2022
• Results First Posted: May 9, 2016

Record last verified: 2016-04

Locations

BU (1)