Skip to main content

SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention.

Publication ,  Journal Article
Tcheng, JE; Gibson, M; Krucoff, MW; Patel, MR; Ajit, M; Hiremath, J; Ponde, C; Ramsaran, E; Clark, G; Lader, AS; Beeuwkes, R ...
Published in: J Cardiovasc Pharmacol
August 2020

OBJECTIVE: The natural molecule α-lipoic acid has been shown to be partially cytoprotective through antioxidant and antiapoptotic mechanisms. To obtain an initial assessment of the safety and potential efficacy of a synthetic derivative, CMX-2043, in preventing ischemic complications of percutaneous coronary intervention (PCI) we conducted the Subjects Undergoing PCI and Perioperative Reperfusion Treatment (SUPPORT-1) trial, the first patient experience with this agent. METHODS AND RESULTS: SUPPORT-1 was a phase 2a, 6-center, international, placebo-controlled, randomized, double-blind trial. A total of 142 patients were randomized to receive a single intravenous bolus dose of drug or placebo administered 15-60 minutes before PCI. Cardiac biomarker assessments included serial measurements of creatine kinase myocardial band (CK-MB) at 6, 12, 18, and 24 hours after PCI and a single measurement of troponin T (TnT) at 24 hours. Peak concentrations of CK-MB and TnT were significantly reduced in the 2.4 mg/kg group compared with placebo (P = 0.05 and 0.03, respectively). No subject administered 2.4 mg/kg of CMX-2043 had an increase of CK-MB to ≥3X upper limit of normal versus 16% for placebo (P = 0.02); 16% of the 2.4-mg/kg dose group developed an elevation of TnT to ≥3X upper limit of normal versus 39% in the placebo group (P = 0.05). No drug-related serious adverse events were observed in any group. CONCLUSION: These data suggest that CMX-2043 may reduce PCI periprocedural myonecrosis and support further clinical evaluation of this novel agent for its potential cytoprotective effects.

Duke Scholars

Published In

J Cardiovasc Pharmacol

DOI

EISSN

1533-4023

Publication Date

August 2020

Volume

76

Issue

2

Start / End Page

189 / 196

Location

United States

Related Subject Headings

  • United States
  • Troponin T
  • Treatment Outcome
  • Time Factors
  • Thioctic Acid
  • Prospective Studies
  • Necrosis
  • Myocytes, Cardiac
  • Middle Aged
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Tcheng, J. E., Gibson, M., Krucoff, M. W., Patel, M. R., Ajit, M., Hiremath, J., … SUPPORT-1 Investigators, . (2020). SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention. J Cardiovasc Pharmacol, 76(2), 189–196. https://doi.org/10.1097/FJC.0000000000000830
Tcheng, James E., Michael Gibson, Mitchell W. Krucoff, Manesh R. Patel, Mullasari Ajit, Jagdish Hiremath, Chandrashekhar Ponde, et al. “SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention.J Cardiovasc Pharmacol 76, no. 2 (August 2020): 189–96. https://doi.org/10.1097/FJC.0000000000000830.
Tcheng, James E., et al. “SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention.J Cardiovasc Pharmacol, vol. 76, no. 2, Aug. 2020, pp. 189–96. Pubmed, doi:10.1097/FJC.0000000000000830.
Tcheng JE, Gibson M, Krucoff MW, Patel MR, Ajit M, Hiremath J, Ponde C, Ramsaran E, Clark G, Lader AS, Beeuwkes R, SUPPORT-1 Investigators. SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention. J Cardiovasc Pharmacol. 2020 Aug;76(2):189–196.

Published In

J Cardiovasc Pharmacol

DOI

EISSN

1533-4023

Publication Date

August 2020

Volume

76

Issue

2

Start / End Page

189 / 196

Location

United States

Related Subject Headings

  • United States
  • Troponin T
  • Treatment Outcome
  • Time Factors
  • Thioctic Acid
  • Prospective Studies
  • Necrosis
  • Myocytes, Cardiac
  • Middle Aged
  • Male