Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial Infarction: the randomized multicentre CASTEMI study.
OBJECTIVE
To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).


RESULTS
STEMI patients (n=387) with > or =10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted.


CONCLUSIONS
This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.
Bär
Frits W
FW
Department of Cardiology, University Hospital Maastricht, PO Box 5800, 6202 AZ Maastricht, The Netherlands. f.baer@cardio.azm.nl
Tzivoni
Dan
D
Dirksen
Maurits T
MT
Fernández-Ortiz
Antonio
A
Heyndrickx
Guy R
GR
Brachmann
Johannes
J
Reiber
Johan H C
JH
Avasthy
Neelima
N
Tatsuno
Jun
J
Davies
Martin
M
Hibberd
Mark G
MG
Krucoff
Mitchell W
MW
D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D001557:Benzenesulfonates / Q000008:administration & dosage*; D002316:Cardiotonic Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000628:therapy*; D010879:Piperazines / Q000008:administration & dosage*; D016896:Treatment Outcome
D001557:Benzenesulfonates; D002316:Cardiotonic Agents; D010879:Piperazines; C487217:caldaret