The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial
NCT ID: NCT01438723
Last Updated: 2014-07-29
Study Results
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Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2011-11-30
2014-07-31
Brief Summary
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In patients with a myocardial infarction, occlusion of a coronary artery induces myocardial ischemia and cell death. If untreated, the area of myocardium exposed to this interruption in blood supply, will largely become necrotic. The only way to limit final infarct size, is timely reperfusion of the occluded artery. Paradoxically, however, reperfusion itself can also damage myocardial tissue and contribute to the final infarct size ("reperfusion injury"). Also during coronary artery bypass grafting (CABG), the myocardium is exposed to ischemia and reperfusion, which will induce cell death. Indeed, postoperatively, the plasma concentration of troponin I, a marker of cardiac necrosis, is increased, and associated with adverse outcome. The anti-hyperglycaemic drug metformin has been shown in preclinical studies to be able to reduce ischemia-reperfusion injury and to limit myocardial infarct size. Moreover, metformin therapy improves cardiovascular prognosis in patients with diabetes mellitus. Paradoxically, in patients with diabetes, current practice is to temporarily stop metformin before major surgery for the presumed risk of lactic acidosis, which is a rare complication of metformin. However, here is no evidence that this practice benefits the patient. The investigators hypothesize that pretreatment with metformin can reduce myocardial injury in patients undergoing elective CABG surgery
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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metformin
Metformin
prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
placebo
Placebo
prior to CABG surgery 3 day treatment with placebo capsules three times a day
Interventions
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Metformin
prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
Placebo
prior to CABG surgery 3 day treatment with placebo capsules three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
* Age ≥ 18 years
Exclusion Criteria
* Renal dysfunction (MDRD \< 60 ml/min)
* Elevated liver enzymes (ALAT \> 3 times upper limit of reference range)
* Treatment with dipyridamole or xanthine derivatives
* Recent myocardial infarction (\<2 weeks before inclusion)
* Off-pump surgery
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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RUNMC
Nijmegen, Gelderland, Netherlands
Countries
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References
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El Messaoudi S, Nederlof R, Zuurbier CJ, van Swieten HA, Pickkers P, Noyez L, Dieker HJ, Coenen MJ, Donders AR, Vos A, Rongen GA, Riksen NP. Effect of metformin pretreatment on myocardial injury during coronary artery bypass surgery in patients without diabetes (MetCAB): a double-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):615-23. doi: 10.1016/S2213-8587(15)00121-7. Epub 2015 Jul 12.
Riksen NP, el Messaoudi S, Rongen GA. It takes more than one CAMERA to study cardiovascular protection by metformin. Lancet Diabetes Endocrinol. 2014 Feb;2(2):105-6. doi: 10.1016/S2213-8587(13)70207-9. Epub 2014 Feb 3. No abstract available.
Other Identifiers
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2011-000099-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MetCAB
Identifier Type: -
Identifier Source: org_study_id
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