Status:
COMPLETED
A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
Lead Sponsor:
Abbott
Conditions:
History of Myocardial Infarction
Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Brief Summary
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy
Detailed Description
It is known that only 50% of patients with chronic diseases adhere to medical recommendations; at the same time, high patient adherence significantly improve the survival of patients with chronic dise...
Eligibility Criteria
Inclusion
- Men and women ≥ 18 years of age
- Patients with history of myocardial infarction not earlier than 6 months ago. AND/OR Patients with diagnosis of hypertriglyceridemia
- Patients having been prescribed Omacor (Omega-3 triglycerides \[EPA/DHA = 1.2/1 - 90%\]) for at least 6 months AND who have been taking Omacor no more than 14 days at the time of enrollment into the program.
- Patients who can, in the opinion of the Investigator, himself or through immediate relatives's help complete electronic system of data collection through mobile application or web-browser
- Patients who have signed the consent to participate in this program before entering their data in the electronic Case Report Form (eCRF) and who understand their right to discontinue the program at any time
Exclusion
- Patients taken medicines (except for Omacor) or nutrition supplements containing omega-3 in any proportions at the time of enrollment into the program OR it has been less than 3 months since last dose of medicines or nutrition supplements containing omega-3 taken.
- Female patients during pregnancy or breastfeeding
- Patients with increased sensitivity to the active substance, excipients, and soy
- Patients with exogenous hypertriglyceridemia (type I hyperchylomicronemia)
- Participation in any other clinical or non-clinical study/program at present or within the latest 30 days
- Patients with any other clinical states that make him/her ineligible for the program on the study doctor's opinion based on clinical assessment
Key Trial Info
Start Date :
January 24 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT03415152
Start Date
January 24 2018
End Date
July 1 2019
Last Update
October 12 2020
Active Locations (93)
Enter a location and click search to find clinical trials sorted by distance.
1
Gbuz Amokb Jsc
Astrakhan, Russia, 414056
2
polyclinic GKB №21
Bashkortostan, Russia, 450071
3
GAUZ "BKDTs"
Bryansk, Russia, 241050
4
GP # 1
Chelyabinsk, Russia, 454000