A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults

Cardiovascular Diseases Clinical Trial

— MITIGATE  

Official title:

A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04505098
• Other study ID #: 1597940
• Status: Terminated
• Phase: Phase 4
• Start date: August 7, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: July 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial. The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ASCVD).

Description:

For the MITIGATE study, eligible members receiving care within Kaiser Permanente Northern California (KPNC) will be identified and screened electronically in a 1:10 intervention to control allocation (i.e., IPE vs. usual care) stratified by age and pre-existing respiratory status. Patients randomly assigned and enrolled into the intervention arm will be asked to take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion. Patients assigned to the control arm (i.e., usual care) will be passively followed only electronically via the electronic health record (EHR).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39600
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Able to provide informed consent (for the intervention arm only)
• No prior history of confirmed COVID-19 (i.e., based on a positive FDA-approved assay for SARS-CoV-2 and no documented FDA-approved serological test results for antibodies to SARS-CoV-2 found in health system databases)
• Established ASCVD (i.e., defined as prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, ischemic stroke, and/or peripheral artery disease)
• At least 12 months of continuous health plan membership and prescription drug benefit prior to enrollment
• A registered e-mail address with the health care delivery system in order to facilitate obtaining electronic consent for study participation

Exclusion Criteria:

• Receipt of IPE on or within 12 months before the day of enrollment
• Known hypersensitivity to IPE, fish, and/or shellfish
• Documented use of any omega-3 fatty acid medications or dietary supplements containing omega-3 fatty acids in the EHR
• Women who are pregnant or planning to become pregnant
• Hospitalization for myocardial infarction and/or elective percutaneous coronary intervention within the past 1 month
• Currently receiving triple anti-thrombotic therapy
• Stage D heart failure
• Severe liver disease
• End-stage renal disease requiring chronic dialysis or estimated glomerular filtration rate <15 mL/min/1.73 m2
• Metastatic cancer and/or receiving active systemic chemotherapy
• Institutionalized and/or receiving palliative care

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Covid19
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Drug:
• Icosapent ethyl
2 g by mouth twice daily for at least 6 months

Locations

Country	Name	City	State
United States	Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Amarin Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of participants who die due to any cause		0-12 months
Other	Percentage of participants experiencing a major adverse cardiovascular event	Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke	0-12 months
Other	Percentage of participants experiencing an expanded major adverse cardiovascular event	Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)	0-12 months
Other	Percentage of participants who are hospitalized for heart failure		0-12 months
Other	Percentage of participants who are hospitalized for any reason		0-12 months
Other	Percentage of participants who have an emergency department visit for any reason		0-12 months
Primary	Rate of confirmed viral URIs	Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities)	0-12 months
Secondary	Percentage of patients with moderate or severe confirmed viral URIs	Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) with an oxygen saturation <94% on room air and/or requiring any form of supplemental oxygen.	0-12 months
Secondary	Worst clinical status due to a confirmed viral URI	At any point in time based on a 7-point ordinal scale (i.e., 1 = death, 2 = mechanically ventilated/extracorporeal membrane oxygenation, 3 = high flow supplemental oxygen, 4 = low flow supplemental oxygen, 5 = hospitalized with no supplemental oxygen requirements, 6 = urgent care or emergency department visit not leading to hospitalization, and 7 = no relevant clinical encounters)	0-12 months