MOST

 

MOST…In Brief

2018-10-04

  1. What is the MOST Payment Schedule?

    START-UP:  Payment 1 in the amount of $2,000.00 upon full execution of the FDP Fixed Price Research Clinical Trial Agreement; and, Payment 2 in the amount of $1,500.00 upon receipt of CIRB approval for Study Start-Up.

    SUBJECTS ENROLLED AND ALL REQUIRED FOLLOW-UP VISITS COMPLETED:  After enrollment to one of the study arms (Placebo, Eptifibatide, or Argatroban), the Maximum per subject payment is $3,853.00 + ($1,618.80) = $5,471.80 total. Indirect costs (42% StrokeNet F&A) shown in parentheses. All payments are contingent on receipt of eCRFs at the relevant study visit.

    Payment will be divided into three increments per subject enrolled. Each payment will be inclusive of the 42% StrokeNet F&A where allowed:

    • Payment 1: Issued after Baseline - payment inclusive of Baseline activities:
      Payment of $1,737.80 will be made after verification of receipt of required eCRFs for baseline and successful administration of, at minimum, study drug bolus dose.
       
    • Payment 2: Issued after Day-30 - payment will be inclusive of protocol adherence after baseline activities, up to and including Day-30 activities:
      Payment of $1,134.00 will be made after verification of receipt of required eCRFs for activities in the interval.
       
    • Payment 3: Issued after Day-90 - payment will be inclusive of Day-90 activities:
      Payment of $2,600.00 will be made after verification of receipt of required eCRFs for Day-90 activities and verification of mRS video recording uploaded to secure server for independent scoring of mRS at 90-Day visit.
  2. What safety data supports the MOST trial?

    Six phase 2 clinical trials have been competed to study the safety of argatroban and eptifibatide in combination with alteplase in Acute Ischemic Stroke:

    MOST_safety_tbl
     
  3. If the patient’s exam improves or good recanalization is achieved before study drug is administered, should study drug still be given?

    Yes – study drug should be administered within 60 minutes of alteplase in subjects eligible prior to alteplase treatment, even if there is clinical improvement or good recanalization before study drug is started because:

    • IV rt-PA alone opens ~50% of occluded arteries; 14-34% reocclude leading to worse outcomes
    • Based on ET treated patients in published trials, 31% did not achieve good recanalization and 25% had persistent occlusion at 24 hours