Clinical trial NCT04505098: A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Official title: A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Covid19
Atherosclerosis
Cardiovascular Diseases
Upper Respiratory Tract Infections
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Amarin Corporation
First posted: 2020-08-10
Enrollment: 39600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized clinical trial
Primary purpose: PREVENTION

Brief 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of confirmed viral URIs
timeFrame: 0-12 months
Secondary outcomes:
measure: Percentage of patients with moderate or severe confirmed viral URIs
timeFrame: 0-12 months
measure: Worst clinical status due to a confirmed viral URI
timeFrame: 0-12 months
Other outcomes:
measure: Percentage of participants who die due to any cause
timeFrame: 0-12 months
measure: Percentage of participants experiencing a major adverse cardiovascular event
timeFrame: 0-12 months
measure: Percentage of participants experiencing an expanded major adverse cardiovascular event
timeFrame: 0-12 months
measure: Percentage of participants who are hospitalized for heart failure
timeFrame: 0-12 months
measure: Percentage of participants who are hospitalized for any reason
timeFrame: 0-12 months
measure: Percentage of participants who have an emergency department visit for any reason
timeFrame: 0-12 months
Locations:
city: Oakland
country: United States
facility: Division of Research
state: California
Study officials:
References: