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

Primary Purpose

Covid19, Atherosclerosis, Cardiovascular Diseases

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Icosapent ethyl
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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)

Full Information

First Posted
August 5, 2020
Last Updated
July 14, 2023
Sponsor
Kaiser Permanente
Collaborators
Amarin Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04505098
Brief Title
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Acronym
MITIGATE
Official Title
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was suspended by the IRB of record and subsequently terminated
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Amarin Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Atherosclerosis, Cardiovascular Diseases, Upper Respiratory Tract Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic randomized clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Icosapent ethyl
Other Intervention Name(s)
Vascepa
Intervention Description
2 g by mouth twice daily for at least 6 months
Primary Outcome Measure Information:
Title
Rate of confirmed viral URIs
Description
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)
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Percentage of patients with moderate or severe confirmed viral URIs
Description
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.
Time Frame
0-12 months
Title
Worst clinical status due to a confirmed viral URI
Description
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)
Time Frame
0-12 months
Other Pre-specified Outcome Measures:
Title
Percentage of participants who die due to any cause
Time Frame
0-12 months
Title
Percentage of participants experiencing a major adverse cardiovascular event
Description
Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke
Time Frame
0-12 months
Title
Percentage of participants experiencing an expanded major adverse cardiovascular event
Description
Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)
Time Frame
0-12 months
Title
Percentage of participants who are hospitalized for heart failure
Time Frame
0-12 months
Title
Percentage of participants who are hospitalized for any reason
Time Frame
0-12 months
Title
Percentage of participants who have an emergency department visit for any reason
Time Frame
0-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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