Health Condition 1: null- Myocardial injury after non cardiac surgery(MINS) Health Condition 2: I248- Other forms of acute ischemic heart disease
Conditions
Interventions
Intervention1: dabigatran, Omeprazole
: Capsule Dabigatran Etexilate 110 mg, twice daily
Capsule Omeprazole 20 mg, once daily
Duration: 18 months
Intervention2: omeprazole: To determine the impact o
Sponsors
Hamilton Health Sciences Corporation through its Population Health Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA Patients are eligible if they: 1. have undergone noncardiac surgery; 2. are >=45 years of age; 3. have suffered MINS based upon fulfilling one of the following criteria1 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 4. provide written informed consent to participate while still in hospital after their index surgery and within 5 days of suffering their MINS.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA We will exclude patients meeting any of the following criteria: 1. hypersensitivity or known allergy to dabigatran; 2. history of intracranial, intraocular, or spinal bleeding; 3. hemorrhagic disorder or bleeding diathesis; 4. known hepatic impairment or liver disease expected to have an impact on survival; 5. condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart valve, venous thromboembolism, atrial fibrillation); 6. currently using or plan to initiate rifampicin, cyclosporine, itraconazole, tacrolimus, ketoconazole, or dronedarone; 7. women who are pregnant, breastfeeding, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study; 8. investigator considers the patient unreliable regarding requirement for study follow-up or study drug compliance; OR 9. previously enrolled in the MANAGE Trial. We will also exclude patients in whom any of the following criteria persist beyond 5 days of their suffering MINS: 1. the attending surgeon believes it is not safe to initiate therapeutic dose anticoagulation therapy; 2. the attending physician believes ASA, intermittent pneumatic compression, or elastic stockings are not sufficient for venous thromboembolism (VTE) prophylaxis and that the patient requires a prophylactic-dose anticoagulant; 3. the patient has an indwelling epidural or spinal catheter that cannot be removed, or the first dose of dabigatran will occur within 4 hours of epidural catheter removal; OR 4. estimated glomerular filtration rate (eGFR) 5. it is expected that the patient will undergo cardiac catheterization for MINS. Exclusion Criteria Specific to Patients in the Omeprazole Factorial Component of the Trial We will exclude patients meeting any of the following criteria: 1. hypersensitivity or known allergy to omeprazole; 2. requirement for a proton pump inhibitor, an H2-receptor antagonist, sucralfate, atazanavir, clopidogrel, or misoprostol; 3. esophageal or gastric variceal disease; OR 4. patient declines participation in the omeprazole arm of MANAGE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of dabigatran versus placebo on the risk of a major vascular complication and, to determine the effect of omeprazole versus placebo on the risk of a major upper gastrointestinal complication in patients who have suffered MINS and are followed on average for 1 year.Timepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of dabigatran on each of the following individual secondary outcomes after MINS and an average of 1 year of follow-up: all-cause mortality, vascular mortality, myocardial infarction, stroke, cardiac revascularization procedure, symptomatic venous thromboembolism (i.e., symptomatic pulmonary embolism or symptomatic deep venous thrombosis), amputation, peripheral arterial thrombosis, and rehospitalization for vascular reasons.Timepoint: one year | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Israel, Italy, Kenya, Netherlands, Nigeria, Peru, Philippines, Poland, Portugal, Russian Federation, South Africa, Spain, United Kingdom, United States of America
Contacts
Public ContactMrs Nandini Mathur
St. Johns Medical College
Outcome results
None listed