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Coronary Artery Bypass Graft SurgeryPhase 3NCT00402506

A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG

A Phase 3 study testing (MC-1) Pyridoxal 5'-phosphate in people with Coronary Artery Bypass Graft Surgery and Myocardial Ischemia, run by Medicure at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG) surgery compared with placebo. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
(MC-1) Pyridoxal 5'-phosphate
How many people
3,000 participants
Where
2 sitesin 2 countries
Study dates
Nov 2006to Sep 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be scheduled to undergo CABG surgery (during routine scheduling times) and had planned to use cardiopulmonary bypass.
  • Provide informed consent
  • Age ≥ 18
  • Male patients, or female patients not of childbearing potential or who have had a negative pregnancy test and are practicing adequate contraception
  • Patients must be considered at high risk for subsequent myocardial complications defined as meeting 2 or more of the following:
  • Age ≥ 65
Show all 19Show fewer
  • Current or recent smoker (within last 6 months)
  • History of diabetes mellitus requiring treatment other than diet
  • Evidence of left ventricular dysfunction or congestive heart failure assessed by:
  • Ejection fraction (EF) ≤ 45%
  • Left ventricular end diastolic pressure (LVEDP) or pulmonary wedge pressure (PWP) ≥ 20 mm Hg
  • Pulmonary edema by chest X-ray
  • Cardiothoracic ratio > 50% on chest X-ray
  • History of a previous non-disabling stroke, transient ischemic attack, or carotid endarterectomy
  • Urgent CABG intervention defined as the need to stay in the hospital (although patient may be operated on within a normal scheduling routine)
  • History of a myocardial infarction that occurred more than 48 hours but less than 6 weeks prior to CABG surgery
  • Prior peripheral artery surgery or angioplasty
  • Moderate renal dysfunction defined as creatinine clearance ≥ 30 ml/min, but < 60 ml/min
  • Presence of at least one asymptomatic carotid artery stenosis (≥ 50%) either in one or two carotid arteries

Who cannot join

  • Planned associated valve surgery or concurrent carotid endarterectomy
  • Planned aortic dissection repair or aortic root reconstruction
  • Screening visit occurring less than 4 hours before scheduled CABG surgery
  • Mini-Mental State Examination (MMSE) score less than 24 at the screening visit
  • Current cardiogenic shock, acute left ventricular rupture, ventricular septal rupture, or papillary muscle rupture
  • Uncontrolled diabetes defined as fasting serum blood glucose value equal to or greater than 24 mmol/L (432 mg/dl) at the time of screening (if fasting serum blood glucose not obtained at screening, values obtained within 30 days prior to screening visit may be used)
Show all 17Show fewer
  • Myocardial infarction occurring < 48 hours prior to planned CABG surgery
  • Severe renal dysfunction defined as an estimated creatinine clearance value of < 30 ml/min or nephrotic syndrome at screening (or measured creatinine clearance value obtained within 30 days prior to screening visit)
  • History of liver cirrhosis, chronic active hepatitis (known positive serum test within 6 months of enrolment), or severe liver dysfunction; or liver transaminase ≥ 3 times upper limit of normal (ULN) at screening (or obtained within 30 days prior to screening visit).
  • History of malignancy during last 5 years except for basal cell carcinoma
  • Planned surgery for atrial fibrillation
  • Planned associated transmyocardial revascularization
  • Planned associated ventricular remodeling
  • Pregnancy or potential for pregnancy
  • Any medical or psychiatric condition which, in the opinion of the investigator, makes the patient an unsuitable candidate for the study
  • Significant, ongoing alcohol or drug abuse
  • Participation in any other investigational drug or device study within 30 days of randomization

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Duke Clinical Research Institute

    Durham, North Carolina, 27705

Other trials in United States

Canada1 site

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

Official title: MEND-CABG II: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG Surgery

The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG) surgery compared with placebo.

Read the detailed description

Coronary artery bypass grafting (CABG) effectively relieves angina, results in longer survival, and a better quality of life in specific subgroups of patients with obstructive coronary artery disease. Due to the high incidence of coronary artery disease worldwide, as well as the effectiveness of the surgical procedure, CABG surgery makes up one of the top ten most frequently performed procedures in North America and Europe. In the United States it is estimated that approximately 467,000 CABG procedures were performed in 2003.

Despite the benefits of CABG surgery, patients undergoing these procedures may also suffer serious adverse outcomes including operative mortality, myocardial infarction, unstable angina, ventricular failure, life-threatening arrhythmia, renal insufficiency, and stroke. Some of the proposed causes of cardiovascular morbidity and mortality after CABG include perioperative ischemia, inadequate myocardial protection and reperfusion injury. The impact of these serious complications is significant. Incidence rates of death and MI following CABG surgery range from 5% to 12% depending on risk status. Results from large clinical trials have recently demonstrated the importance of neurologic deficits as a problematic outcome of CABG. These deficits include memory impairment, psychomotor, visuospatial, attention and language abilities as measured by neuropsychological testing as well as sensorimotor abnormalities associated with stroke.

MC-1 is a naturally occurring metabolite of vitamin B6. Evidence from pre-clinical and clinical studies suggests that MC-1 protects the heart from ischemic damage and ischemia-reperfusion injury. This trial will assess the cardioprotective effects of MC-1 compared to placebo in patients undergoing high-risk CABG surgery.

Being tested
(MC-1) Pyridoxal 5'-phosphate
Keywords
coronary, surgery, ischemia, reperfusion injury, cardiac, heart, neurological, cardiopulmonary bypass, cardioprotection, myocardium, myocardial, myocardial revascularization
Medical subject headings
Myocardial Ischemia, Reperfusion Injury, Ischemia, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (MC-1) Pyridoxal 5'-phosphateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. combined incidence of cardiovascular death or nonfatal myocardial infarction on days up to and including post-operative day (POD) 30

Secondary outcomes (3)

  1. length of hospital stay for index hospitalization

  2. length of stay in intensive care unit (ICU) or coronary care unit (CCU) for index hospitalization

  3. incidence of cardiovascular death up to and including POD 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402506
Sponsor's protocol ID
06004
Status last verified
Nov 2007
First submitted
20 Nov 2006
Last updated
16 Nov 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Kandzari DE, Labinaz M, Cantor WJ, Madan M, Gallup DS, Hasselblad V, Joseph D, Allen A, Green C, Hidinger KG, Krucoff MW, Christenson RH, Harrington RA, Tcheng JE. Reduction of myocardial ischemic injury following coronary intervention (the MC-1 to Eliminate Necrosis and Damage trial). Am J Cardiol. 2003 Sep 15;92(6):660-4. doi: 10.1016/s0002-9149(03)00818-x.

    PubMed 12972102

  • MEND-CABG II Investigators; Alexander JH, Emery RW Jr, Carrier M, Ellis SJ, Mehta RH, Hasselblad V, Menasche P, Khalil A, Cote R, Bennett-Guerrero E, Mack MJ, Schuler G, Harrington RA, Tardif JC. Efficacy and safety of pyridoxal 5'-phosphate (MC-1) in high-risk patients undergoing coronary artery bypass graft surgery: the MEND-CABG II randomized clinical trial. JAMA. 2008 Apr 16;299(15):1777-87. doi: 10.1001/jama.299.15.joc80027. Epub 2008 Apr 1.

    PubMed 18381567

  • Mehta RH, Alexander JH, Emery R, Ellis SJ, Hasselblad V, Khalil A, Carrier M, Harrington RA, Tardif JC; MEND-CABG II Investigators. A randomized, double-blind, placebo-controlled, multicenter study to evaluate the cardioprotective effects of MC-1 in patients undergoing high-risk coronary artery bypass graft surgery: MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery Trial (MEND-CABG) II--study design and rationale. Am Heart J. 2008 Apr;155(4):600-8. doi: 10.1016/j.ahj.2008.01.002. Epub 2008 Feb 21.

    PubMed 18371465

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing (MC-1) Pyridoxal 5'-phosphate in people with Coronary Artery Bypass Graft Surgery and Myocardial Ischemia, run by Medicure at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

combined incidence of cardiovascular death or nonfatal myocardial infarction on days up to and including post-operative day (POD) 30. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402506, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2007.

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