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Research

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MANAGE

Official Title

Management of myocardial injury after noncardiac surgery

Status

Ongoing

Overview

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 will be used to randomize patients not already on a proton pump inhibitor to either omeprazole or matching placebo.This trial will involve almost 30 countries with approximately 160 sites. The target sample size is 3,200 patients for the main trial with an expected 1,920 patients in the omeprazole factorial. The trial will 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 will be followed-up for an average of one year post-randomization.

Study Design

Randomized, blinded, placebo control, factorial assignment.

Primary Endpoint

Primary: Major vascular complication (composite of vascular mortality, nonfatal myocardial infarction, nonfatal stroke, nonfatal peripheral arterial thrombosis and nonfatal symptomatic pulmonary embolism); Secondary: Major upper gastrointestinal complication (composite of overt gastroduodenal bleeding, overt upper gastrointestinal bleeding of unknown origin, or upper gastrointestinal perforation)

Number of Patients

3200

Number of Sites

160

Number of Countries

28

Study Period

2013–2016

Principal Investigator

P.J. Devereaux

Program Manager

Susan Chrolavicius, Shirley Pettit

Research Coordinator

Jessica Vincent