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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01661101




Registration number
NCT01661101
Ethics application status
Date submitted
7/08/2012
Date registered
9/08/2012
Date last updated
26/03/2018

Titles & IDs
Public title
Management of Myocardial Injury After Noncardiac Surgery Trial
Scientific title
A Large, International, Randomized, Placebo-controlled Trial to Assess the Impact of Dabigatran (a Direct Thrombin Inhibitor) and Omeprazole (a Proton-pump Inhibitor) in Patients Suffering Myocardial Injury After Noncardiac Surgery
Secondary ID [1] 0 0
2011-006056-37
Secondary ID [2] 0 0
1160.143
Universal Trial Number (UTN)
Trial acronym
MANAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Injury After Noncardiac Surgery (MINS) 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dabigatran
Treatment: Drugs - Placebo (for Dabigatran)
Treatment: Drugs - Omeprazole
Treatment: Drugs - Placebo (for Omeprazole)

Experimental: Dabigatran - Dabigatran 110 mg capsule taken twice daily

Experimental: Omeprazole - Omeprazole 20 mg capsule taken once daily

Placebo comparator: Placebo (dabigatran) - Dabigatran placebo taken twice daily

Placebo comparator: Placebo (omeprazole) - Omeprazole placebo taken once daily


Treatment: Drugs: Dabigatran
Dabigatran 110 mg taken twice daily

Treatment: Drugs: Placebo (for Dabigatran)
Dabigatran placebo taken twice daily

Treatment: Drugs: Omeprazole
Omeprazole 20 mg capsule taken once daily

Treatment: Drugs: Placebo (for Omeprazole)
Omeprazole placebo taken once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major vascular complication (for Dabigatran)
Timepoint [1] 0 0
Average of 1 year follow-up
Primary outcome [2] 0 0
Major upper gastrointestinal complication (for Omeprazole)
Timepoint [2] 0 0
Average of 1 year follow-up
Secondary outcome [1] 0 0
Individual secondary outcomes for Dabigatran
Timepoint [1] 0 0
Average of 1 year follow-up
Secondary outcome [2] 0 0
Upper gastrointestinal complication for Omeprazole
Timepoint [2] 0 0
Average of 1 year follow-up
Secondary outcome [3] 0 0
Major vascular complication for Omeprazole
Timepoint [3] 0 0
Average of 1 year follow-up
Secondary outcome [4] 0 0
Individual secondary outcomes for Omeprazole
Timepoint [4] 0 0
Average of 1 year follow-up
Secondary outcome [5] 0 0
Safety outcomes for Dabigatran
Timepoint [5] 0 0
Average of 1 year follow-up
Secondary outcome [6] 0 0
Safety outcomes for Omeprazole
Timepoint [6] 0 0
Average of 1 year follow-up

Eligibility
Key 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 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
4. provide written informed consent to participate within 35 days of suffering their MINS.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:

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.

Also excluded will be patients in whom any of the following criteria persist beyond 35 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) <35 ml/min as estimated by calculated creatinine clearance.
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:

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2018
Sample size
Target
Accrual to date
Final
1754
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kansas
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Brazil
State/province [10] 0 0
Minas Gerais
Country [11] 0 0
Brazil
State/province [11] 0 0
Paraná
Country [12] 0 0
Brazil
State/province [12] 0 0
Belo Horizonte
Country [13] 0 0
Brazil
State/province [13] 0 0
Campinas
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio de Janeiro
Country [15] 0 0
Brazil
State/province [15] 0 0
São José do Rio Preto
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Colombia
State/province [20] 0 0
Santander
Country [21] 0 0
Colombia
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Bogota
Country [22] 0 0
Czechia
State/province [22] 0 0
Liberec
Country [23] 0 0
Czechia
State/province [23] 0 0
Motol
Country [24] 0 0
Denmark
State/province [24] 0 0
Copenhagen
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Denmark
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Herlev
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Denmark
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Hillerød
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Denmark
State/province [27] 0 0
Køge
Country [28] 0 0
Denmark
State/province [28] 0 0
Vejle
Country [29] 0 0
France
State/province [29] 0 0
Lyon
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
Germany
State/province [31] 0 0
Hesse
Country [32] 0 0
Germany
State/province [32] 0 0
Bonn
Country [33] 0 0
India
State/province [33] 0 0
Distt- Ludhiana
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India
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Gujarat,
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India
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Kerala
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India
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Bangalore
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India
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Bengaluru
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India
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Lucknow
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India
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Ludhiana
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India
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Nagpur
Country [41] 0 0
India
State/province [41] 0 0
Tiruvannamalai
Country [42] 0 0
Italy
State/province [42] 0 0
Udine
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
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Monza
Country [45] 0 0
Kenya
State/province [45] 0 0
Nairobi
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Peru
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Lima
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Philippines
State/province [47] 0 0
Dasmariñas
Country [48] 0 0
Philippines
State/province [48] 0 0
Manila
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Poland
State/province [49] 0 0
Bochnia
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Brzesko
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Krakow
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Kraków
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Miechów
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Myslenice
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Tarnow
Country [56] 0 0
Poland
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Wloszczowa
Country [57] 0 0
South Africa
State/province [57] 0 0
Kwazulu-Natal
Country [58] 0 0
South Africa
State/province [58] 0 0
Bloemfontein
Country [59] 0 0
South Africa
State/province [59] 0 0
Cape Town
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
United Kingdom
State/province [62] 0 0
North Ireland
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Dudley

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
P.J. Devereaux, MD, PhD
Address 0 0
Population Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01661101