Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE)
Myocardial Injury After Noncardiac Surgery (MINS)
About this trial
This is an interventional treatment trial for Myocardial Injury After Noncardiac Surgery (MINS) focused on measuring Perioperative myocardial infarction, Myocardial injury, noncardiac surgery
Eligibility Criteria
Inclusion Criteria:
Patients are eligible if they:
- 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:
Patients meeting any of the following criteria will be excluded:
- hypersensitivity or known allergy to dabigatran;
- history of intracranial, intraocular, or spinal bleeding;
- hemorrhagic disorder or bleeding diathesis;
- known hepatic impairment or liver disease expected to have an impact on survival;
- condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart valve, venous thromboembolism, atrial fibrillation);
- 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
- previously enrolled in the MANAGE Trial.
Also excluded will be patients in whom any of the following criteria persist beyond 35 days of their suffering MINS:
- the attending surgeon believes it is not safe to initiate therapeutic dose anticoagulation therapy;
- 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;
- 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
- estimated glomerular filtration rate (eGFR) <35 ml/min as estimated by calculated creatinine clearance.
- 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:
Patients meeting any of the following criteria:
- hypersensitivity or known allergy to omeprazole;
- requirement for a proton pump inhibitor, an H2-receptor antagonist, sucralfate, atazanavir, clopidogrel, or misoprostol;
- esophageal or gastric variceal disease; OR
- patient declines participation in the omeprazole arm of MANAGE.
Sites / Locations
- Kansas University Medical Center
- VA Western New York Healthcare System
- University of Rochester Medical Center
- Wake Forest School of Medicine
- Oregon Health and Science University
- Drexel University College of Medicine
- VA North Texas Health Care System Dallas VA Medical Center
- Instituto Cardiovascular de Buenos Aires
- Clinica Parra - Centro de Investigaciones
- Sanatorio San Martin
- Favaloro Foundation
- Hospital San Roque
- Westmead Hospital
- Hospital Maternidade
- Sociendade Hospitalar Angelina Caron
- Hospital Lifecenter
- Hospital e Maternidade Celso Pierro - PUCCAMP
- Hospital Barra D'Or
- Hospital de Base
- Grey Nuns Hospital
- University of Alberta Hospital
- Health Sciences Centre Winnipeg
- Hamilton General Hospital
- St. Joseph's Healthcare Hamilton
- Juravinski Hospital and Cancer Centre
- Queens University - Kingston General Hospital
- University Hospital, London Health Sciences Centre
- Victoria Hospital, London Health Sciences Centre
- Centre Hospitalier Universitaire de Montreal - St. Luc Hospital
- Montreal General Hospital - McGill University Health Centre
- Clinica Foscal
- Fundacion Cardioinfantil - Instituto de Cardiologia
- Liberec Regional Hospital
- University Hospital Motol
- Bispebjerg Hospital, University of Copenhagen
- Copenhagen University Hospital, Rigshospitalet
- Herlev Hospital
- Nordsjaellands Hospital
- Koege-Roskilde Hospital
- Vejle Hospital
- Hospice Civils de Lyon
- Hospitalier Pitie Salpetriere
- Klinikum der J. W. Goethe-Universität Frankfurt
- Universitätsklinikum Bonn
- Sidhu Hospital
- Surat Institute of Digestive Sciences
- Amrita Institute of Medical Sciences and Research Institute
- M.S. Ramaiah Medical College & Hospitals
- Narayana Hrudayalaya
- M.V. Hospital & Research Centre
- Christian Medical College
- Rahate Surgical Hospital
- Ramana Maharishi Rangammal Hospital
- Sant'Antonio Hospital
- Azienda Ospedaliera Niguarda Ca'Granda
- IRCCS Istituto Ortopedico Galeazzi Milan
- IRCCS San Raffaele Scientific Institute
- Ospedale San Gerardo
- Aga Khan University Hospital - Nairobi
- Hospital Nacional Cayetano Heredia
- De La Salle University Medical Center
- Philippines General Hospital
- SPZOZ Szpital Powiatowy w Bochni
- Spzoz w Brzesku
- Malopolskie Centrum Medyczne
- OrtoMed sp. Z.o.o.
- Samodzielny Publiczny Zakład Opieki
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
- Szpital św. Anny w Miechowie
- Spzoz w Myslenicach
- Specjalistyczny Szpital im. E. Szczeklika
- Zakład Opieki Zdrowotnej im. Jana Pawła II
- University of Kwazulu-Natal
- Grey's Hospital
- University of the Free State
- University of Cape Town
- Bellvitge University Hospital
- Hospital de la Santa Creu I Sant Pau
- Hospital Universatario Valle Hebron
- Hospital Universitario Ramon y Cajal
- Belfast Health and Social Care Trust, Royal Victoria Hospital
- Russell Halls Hospital, Dudley Group NHS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Dabigatran
Omeprazole
Placebo (dabigatran)
Placebo (omeprazole)
Dabigatran 110 mg capsule taken twice daily
Omeprazole 20 mg capsule taken once daily
Dabigatran placebo taken twice daily
Omeprazole placebo taken once daily