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.
RCT Entities:
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 MIpatients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.
Authors: Lea K Seidlmayer; Vanessa V Juettner; Sarah Kettlewell; Evgeny V Pavlov; Lothar A Blatter; Elena N Dedkova Journal: Cardiovasc Res Date: 2015-03-05 Impact factor: 10.787
Authors: Lisa Schwartz Longacre; Robert A Kloner; Andrew E Arai; Christopher P Baines; Roberto Bolli; Eugene Braunwald; James Downey; Raymond J Gibbons; Roberta A Gottlieb; Gerd Heusch; Robert B Jennings; David J Lefer; Robert M Mentzer; Elizabeth Murphy; Michel Ovize; Peipei Ping; Karin Przyklenk; Michael N Sack; Richard S Vander Heide; Jakob Vinten-Johansen; Derek M Yellon Journal: Circulation Date: 2011-09-06 Impact factor: 29.690