Landmark Research Studies
completed

The objective of the MANAGE trial was to assess the impact of dabigatran (a direct thrombin inhibitor) in patients suffering myocardial injury after noncardiac surgery (MINS).

In addition, a partial 2×2 factorial design was used to randomize patients not already on a proton pump inhibitor to either omeprazole or matching placebo.

The trial intended to determine the effect of dabigatran 110 mg versus matching placebo on the risk of major vascular complications, and the effect of omeprazole 20 mg versus matching placebo on the risk of major upper gastrointestinal complications in patients who have suffered MINS. Patients were followed-up for an average of one year post-randomization.

Primary endpoints:

  • Major vascular complication (composite of vascular mortality
  • Nonfatal myocardial infarction
  • Nonfatal stroke
  • Nonfatal peripheral arterial thrombosis
  • Nonfatal symptomatic pulmonary embolism

Secondary endpoint:

Major upper gastrointestinal complication (composite of overt gastroduodenal bleeding, overt upper gastrointestinal bleeding of unknown origin, or upper gastrointestinal perforation)

Download Presentation PDF
Study Type

Interventional - Drug

Study Design

­­­­­­­­­­­Multicentre, international, 2x2 partial factorial RCT

NO. of Countries

21

NO. of Sites

115

NO. of Participants

1042

Study Period

2013-2018

Sponsor

PHRI

PJ Devereaux discusses MANAGE study at ESC 2018

Back To Top