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Omega-3 Fatty Acid

Intervention for Cardiovascular Disease (MITIGATE Trial)

Phase 4
Waitlist Available
Led By Andrew Ambrosy, M.D.
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-12 months
Awards & highlights

MITIGATE Trial Summary

This trial will compare the effects of a drug called icosapent ethyl (or Vascepa) to usual care in preventing illness and death from viral respiratory infections like COVID-19 in people with atherosclerotic cardiovascular disease.

Eligible Conditions
  • Cardiovascular Disease
  • Atherosclerosis
  • Coronavirus
  • Common Cold

MITIGATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of confirmed viral URIs
Secondary outcome measures
Percentage of patients with moderate or severe confirmed viral URIs
Worst clinical status due to a confirmed viral URI
Other outcome measures
Percentage of participants experiencing a major adverse cardiovascular event
Percentage of participants experiencing an expanded major adverse cardiovascular event
Percentage of participants who are hospitalized for any reason
+3 more

MITIGATE Trial Design

2Treatment groups
Active Control
Group I: InterventionActive Control1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
537 Previous Clinical Trials
24,074,099 Total Patients Enrolled
Amarin CorporationUNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Andrew Ambrosy, M.D.Principal InvestigatorKaiser Permanente

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for participants in this examination?

"Unfortunately, recruitment for this trial has since ended. It was initially posted on the 8th of July 2020 and last updated on January 7th 2022. However, there are currently 802 clinical trials looking to enrol patients with cardiovascular diseases as well as 5 studies involving interventions that are actively recruiting volunteers."

Answered by AI

What risks may patients undertake with intervention treatments?

"Our team has determined that Intervention is a safe option with a score of 3, as it is currently approved by the FDA and in Phase 4 trials."

Answered by AI

What is the current enrolment size for this clinical trial?

"This clinical research is not currently seeking participants, having last been amended on January 7th 2022. Nonetheless, those searching for related trials can find 802 studies actively recruiting patients with cardiovascular diseases and 5 intervention-based experiments that are open to enrollment."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
Kaiser Permanente Northern California
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
2020. "A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505098.
~8486 spots leftby Apr 2025
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