|Description||A large, international, placebo-controlled, trial to assess the impact of dabigatran (a direct thrombin inhibitor) and omeprazole (a proton-pump inhibitor) in patients suffering a myocardial infarction after noncardiac surgery.|
|Date Opened to Recruitment|
|Target Recruitment||200 (UK) 3200 (Total)|
|Recruitment to date||0 (UK) 161 (Total)|
|Trial Design||Study Design: Randomized, Blinded, Placebo Control, Factorial Assignment.Intervention: Dabigatran vs. matching placebo, omeprazole vs. matching placebo.
Length of Study: 2 year recruitment period, minimum 6 months follow-up period.
|Study Aim||Primary Aim: -To determine the effect of dabigatran versus placebo on the risk of a major vascular complication (i.e., a
composite of vascular mortality, nonfatal myocardial infarction, nonfatal stroke, nonfatal peripheral
arterial thrombosis, and nonfatal symptomatic pulmonary embolism) and, to determine the effect of
omeprazole versus placebo on the risk of a major upper gastrointestinal complication (i.e., a composite of
overt gastroduodenal bleeding, overt upper gastrointestinal bleeding of unknown origin, or upper
gastrointestinal perforation) in patients who have suffered MINS and are followed on average for 1 year.
|Chief Investigator||Dr PJ Devereaux|
|National Co-ordinator Lead||Dr Martin Shields|
|Sponsor||Population Health Research Institute (PHRI)|
|Funder||Population Health Research Institute (PHRI)|