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

Search all trials

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
Conditions the study is for: Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury
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

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.

Country

City, postcode or hospital

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

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.

Conditions: Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury
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.

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

Secondary outcomes (3)

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

Nov 2006Sep 2007

First posted22 Nov 2006 (estimated)
Study startNov 2006
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Recruiting
Additional Effects of Flutter With Conventional Chest Physiotherapy on Peak Expiratory Flow Rate and Chest Expansion in Post CABG Patients With COPD
Peak Expiratory Flow Rate, Coronary Artery Bypass Graft Surgery
Not yet recruitingObservational study
Epigenetic Susceptibility to Inflammatory Complications After Cardiac Surgery
Organ Dysfunction, Inflammation in Cardiac Surgery
Not yet recruiting
BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
Not yet recruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)

All Coronary Artery Bypass Graft Surgery trials