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The MC-1 to Eliminate Necrosis and Damage (MEND-1) trial studied sixty patients scheduled for elective percutaneous coronary intervention (PCI) who were randomized to treatment with MC-1 or placebo in a 2:1 fashion. MC-1 is a vitamin B6 metabolite. The trial itself was designed as a pilot study. The sponsor was hoping for smaller CK-MB values in the treated arm, but did not realistically expect a significant difference. The primary endpoint was defined as infarction size measured by area under the curve (AUC) creatine kinase MB (CK-MB). CK-MB is an enzyme marker which is a measure of heart damage. It is often used to confirm a heart attack. The measurement has a minimum detectable level of 0.4 so that no peak value is lower than 0.4.
Another measure which is highly correlated with the AUC is the peak CK-MB. This is defined as the maximal value over the 24 hour period. The actual observed peaks and AUC values are given below.
The results were so encouraging that the sponsor is just starting a Phase II trial with the name MEND-CAGB.
Sample size requirements were determined by the needs of evaluating the feasibility of the trial and not on considerations of statistical power per se. The trial will consist of 60 patients: 20 randomized to the placebo group and 40 to the MC-1 group.
Treated
Peak AUC
1.1 18.615
0.9 10.734
12.4 116.808
0.6 10.067
1.6 23.379
0.4 9.6
0.8 .
0.4 9.6
0.5 10.213
0.5 9.313
3.1 32.352
0.4 9.033
0.4 8.567
0.5 11.208
0.4 9.6
4.4 57.953
3.9 65.763
10.2 129.067
1.5 24.383
0.4 8.6
0.6 11.933
0.7 12.363
1.4 26.3
2.2 28.434
0.4 .
1.9 20.717
0.4 .
5.5 57.655
0.8 15.517
1.3 17.7
4.6 86.096
2.4 38.883
2.2 37.135
0.6 10.825
2.3 30.993
1 16.358
1.3 23.835
15.3 .
2.6 34.45
Control
Peak AUC
1.5 19.375
0.5 9.112
0.7 11.999
1.4 27.15
2 35.3
2.6 47.021
6.2 50.575
2.8 34.467
2 23.708
9 122.955
0.8 13.283
1.6 31.392
10 120.449
1.5 .
6.7 64.308
6.3 83.393
0.8 14.092
6.7 75.258
1.6 28.888