MedTrace Logo

Management of Myocardial Injury After Noncardiac Surgery Trial

NCT01661101 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1754

Last updated 2018-03-26

No results posted yet for this study

Summary

Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying than those who do not. One in 10 patients with myocardial injury will die within 30 days of surgery. This risk of death exists up to one year after myocardial injury. There are currently no treatments or guidelines available for heart injury after surgery, but there is evidence that taking a blood-thinner can prevent some of the deaths, both in the short and long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and omeprazole) that may prevent mortality, major cardiovascular complications and major upper gastrointestinal bleeding in patients who have had myocardial injury after noncardiac surgery.

Conditions

  • Myocardial Injury After Noncardiac Surgery (MINS)

Interventions

DRUG

Dabigatran

Dabigatran 110 mg taken twice daily

DRUG

Placebo (for Dabigatran)

Dabigatran placebo taken twice daily

DRUG

Omeprazole

Omeprazole 20 mg capsule taken once daily

DRUG

Placebo (for Omeprazole)

Omeprazole placebo taken once daily

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • P.J. Devereaux, MD, PhD · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-03-01
Completion
2018-03-01

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • India
  • Italy
  • Kenya
  • Peru
  • Philippines
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01661101 on ClinicalTrials.gov