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NCT01661101 · ClinicalTrials.gov registry record · Phase 3

Management of Myocardial Injury After Noncardiac Surgery Trial

A Phase 3 study, sponsored by Population Health Research Institute.

Completed
Registry status
Phase 3
Development phase
1,754
Enrollment target

NCT01661101 is a Phase 3 study that has completed, run by Population Health Research Institute. The registered enrollment target is 1,754 participants.

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The verdict

NCT01661101, a Phase 3 study, has completed, sponsored by Population Health Research Institute.

COMPLETED
Registry status
Phase 3
Development phase
1,754 participants
Enrollment target

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.

Interventions

  • DRUG Omeprazole
  • DRUG Dabigatran
  • DRUG Placebo (for Dabigatran)
  • DRUG Placebo (for Omeprazole)

Trial Details

FieldValue
Enrollment Target 1,754 participants
Start Date 2013-01
Est. Completion 2018-03-01
Phase Phase 3

What the Registry Record Tells You About NCT01661101

The ClinicalTrials.gov registry entry for NCT01661101 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,754 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Population Health Research Institute, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Omeprazole is the first listed.

NCT01661101 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01661101 about?

NCT01661101 is a clinical study titled "Management of Myocardial Injury After Noncardiac Surgery Trial". 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 guide...

What is the current status of trial NCT01661101?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,754 participants. The study started on 2013-01. Estimated completion is 2018-03-01.

What interventions are being tested in trial NCT01661101?

The interventions under investigation include: Omeprazole (DRUG), Dabigatran (DRUG), Placebo (for Dabigatran) (DRUG), Placebo (for Omeprazole) (DRUG).

Who is sponsoring clinical trial NCT01661101?

This trial is sponsored by Population Health Research Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.