reduction of stroke has never been part of the endpoints in these kinds of trials. Medicure asked it to be part of the endpoint in the phase 2 because the moa of the drug would lead you to believe that it may reduce the symptoms of a stroke. Reducing symptoms of a stroke is a lot different than preventing one from happening. They were naive to have it included as an endpoint.
stroke will be followed as an adverse event where it belongs
in the 250 ml dose the reduction of mi, death and stroke of 37 percent with a p value of .028 would have been closer to 45 percent reduction with a p value less than .01 just by taking stroke out of the numerator. They will have that advantage in the phase 3.
Since it can't prevent a stroke but you track it as an endpoint you are paying a penalty to have it in both the numerator and denominator in your p value calculation.
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