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Whalatane

10/30/20 1:44 PM

#307531 RE: HinduKush #307524

HK. key part the inclusion criteria for MITIGATE


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)



They may have enough in the control arm already ......there has probably been at least 15,000 ( ? ) Kaiser ASCVD prior event patients in the last 6 mths with no Covid .
They just need to match those with 1600 ( ? ) of the same profile who have had Vascepa 4 gm daily added.

Both groups need to stay the same for a minimum of 6 mths

So in the control arm ..... even If you start the recruiting period from the last Covid peak in Nth Ca .....you are probably only asking those patients to not start Vascepa for another 3 mths .

Remember ...this is using electronic records

As we know ...R-IT could have been stopped at Interim 2 ...but DMC decided to continue . Was that ethical ?

Anyway ...thx for emailing the investigators

Kiwi