Management of Myocardial Injury After Noncardiac Surgery Trial (NCT01661101) | Clinical Trial Compass
CompletedPhase 3
Management of Myocardial Injury After Noncardiac Surgery Trial
United States1,754 participantsStarted 2013-01
Plain-language 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.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. have undergone noncardiac surgery;
✓. are ≥45 years of age;
✓. have suffered MINS based upon fulfilling one of the following criteria: A. Elevated troponin or CK-MB measurement with one or more of the following defining features i. ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema); ii. development of pathologic Q waves present in any two contiguous leads that are ≥30 milliseconds; iii. electrocardiogram (ECG) changes indicative of ischemia (i.e., ST segment elevation \[≥2 mm in leads V1, V2, or V3 OR ≥1 mm in the other leads\], ST segment depression \[≥1 mm\], OR symmetric inversion of T waves ≥1 mm) in at least two contiguous leads; iv. new LBBB; or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging B. Elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury; AND
✓. provide written informed consent to participate within 35 days of suffering their MINS.
Exclusion criteria
✕. hypersensitivity or known allergy to dabigatran;
✕. history of intracranial, intraocular, or spinal bleeding;
What they're measuring
1
Major vascular complication (for Dabigatran)
Timeframe: Average of 1 year follow-up
2
Major upper gastrointestinal complication (for Omeprazole)
✕. currently using or plan to initiate rifampicin, cyclosporine, itraconazole, tacrolimus, ketoconazole, or dronedarone;
✕. women who are pregnant, breastfeeding, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study;
✕. investigator considers the patient unreliable regarding requirement for study follow-up or study drug compliance; OR