Amarin Corp Plc (AMRN)

[Whalatane]

Zip. Re MITIGATE ...Outcomes and inclusion specs

Outcome Measures
Go to sections

Primary Outcome Measures :
Percentage of patients with moderate or severe confirmed viral URIs [ Time Frame: 0-12 months ]
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 [ Time Frame: 0-12 months ]
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)


Other Outcome Measures:
Percentage of participants who die due to any cause [ Time Frame: 0-12 months ]
Percentage of participants experiencing a major adverse cardiovascular event [ Time Frame: 0-12 months ]
Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke

Percentage of participants experiencing an expanded major adverse cardiovascular event [ Time Frame: 0-12 months ]
Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)

Percentage of participants who are hospitalized for heart failure [ Time Frame: 0-12 months ]
Percentage of participants who are hospitalized for any reason [ Time Frame: 0-12 months ]
Percentage of participants who have an emergency department visit for any reason [ Time Frame: 0-12 months ]

Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
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)

To some of your points
1) This study is more than just about Covid . It is also IMHO a mini JELIS follow up on secondary prevention prior intervention patients . Notice the area highlighted in Bold above ...followed for 12 mths .
Chk my previous post to posters N7 and gg

2) You can chk the vaccination rates for Sacramento and San Joaquin Counties ...I believe only about 60% are fully vaccinated ......probably higher in the age group studied as Kaiser was very pro active in getting their members vaccinated

3) It is unethical to request people to remain unvaccinated when its clearly documented that the risk of dying or being hospitalized by Covid is FAR less if you are fully vaccinated with a booster

4) IF the spread of Covid continues at its current rate in the MITIGATE trial areas ...this trial will reach the necessary powering within the next 10 days . It will be definitive

Suggest you read my other posts on MITIGATE and review my exchanges with poster N 7

https://rethinkingclinicaltrials.org/news/june-18-2021-the-mitigate-study-insights-from-a-decentralized-virtual-electronic-health-record-based-pragmatic-clinical-trial-andrew-ambrosy-md-alan-go-md/

https://www.researchgate.net/figure/Kaplan-Meier-estimates-of-the-incidence-of-the-primary-endpoint-of-coronary-events_fig3_24409933

Zip ...notice how fast the event curves separate in the prior intervention group ......MITIGATE are prior intervention CAD patients .
Dr Bhatt was involved in designing this study
By June 2022 over 1200 active and 1200 passive patients will have been in this trial for at least 12 mths .
This will be a very important readout out for Dr Bhatt and AMRN IMHO


Kiwi