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The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial (MetCAB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438723
First Posted: September 22, 2011
Last Update Posted: July 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
September 21, 2011
September 22, 2011
July 29, 2014
November 2011
July 2014   (Final data collection date for primary outcome measure)
Hs-Troponin-I [ Time Frame: within 24 hours after CABG ]
high sensitive cardiac troponin-I
Hs-Troponin-I [ Time Frame: within 72 hours after CABG ]
high sensitive cardiac troponin-I
Complete list of historical versions of study NCT01438723 on ClinicalTrials.gov Archive Site
  • Post operative occurrence of arrhythmias [ Time Frame: within 24 hours after CABG ]
  • Duration of inotropic support [ Time Frame: within two days after CABG ]
  • Time to detubation [ Time Frame: within two days after CABG ]
  • Post-ischemic recovery of contractile function of atrial trabeculae [ Time Frame: until 4 hours after harvesting ]
  • Post operative occurrence of arrhythmias [ Time Frame: within 24 hours after CABG ]
  • Duration of inotropic support [ Time Frame: within three days after CABG ]
  • Time to detubation [ Time Frame: within three days after CABG ]
  • Post-ischemic recovery of contractile function of atrial trabeculae [ Time Frame: until 4 hours after harvesting ]
  • renal ischemia-reperfusion injury [ Time Frame: within three days after CABG ]
Not Provided
Not Provided
 
The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial
The Metformin in CABG (MetCAB) Trial

Rationale:

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiovascular Disease
  • Ischemic Heart Disease
  • Drug: Metformin
    prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
    Other Name: Glucophage
  • Drug: Placebo
    prior to CABG surgery 3 day treatment with placebo capsules three times a day
  • Experimental: metformin
    Intervention: Drug: Metformin
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2014
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acceptation for CABG with or without concomitant valve surgery
  • Informed consent
  • Age ≥ 18 years

Exclusion Criteria:

  • Diabetes mellitus
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01438723
MetCAB
2011-000099-33 ( EudraCT Number )
Yes
Not Provided
Not Provided
Radboud University
Radboud University
Not Provided
Not Provided
Radboud University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP