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

Eur Heart J. 2006 Nov;27(21):2516-23. doi: 10.1093/eurheartj/ehl304. Epub 2006 Oct 9.


Aims: To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

Methods and 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.

Conclusion: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary / methods*
  • Benzenesulfonates / administration & dosage*
  • Cardiotonic Agents / administration & dosage*
  • Female
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Myocardial Infarction / pathology
  • Myocardial Infarction / therapy*
  • Piperazines / administration & dosage*
  • Treatment Outcome


  • Benzenesulfonates
  • Cardiotonic Agents
  • Piperazines
  • caldaret