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Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study.

Publication ,  Journal Article
Becker, RC; Moliterno, DJ; Jennings, LK; Pieper, KS; Pei, J; Niederman, A; Ziada, KM; Berman, G; Strony, J; Joseph, D; Mahaffey, KW; Veltri, E ...
Published in: Lancet (London, England)
March 2009

An antithrombotic drug is needed that safely reduces cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). We therefore assessed the tolerability and safety of SCH 530348-an oral platelet protease-activated receptor-1 antagonist.We randomly assigned patients aged 45 years or older and undergoing non-urgent PCI or coronary angiography with planned PCI to an oral loading dose of SCH 530348 (10 mg, 20 mg, or 40 mg) or matching placebo in a 3:1 ratio in a multicentre international study. Those in the SCH 530348 group who subsequently underwent PCI (primary PCI cohort) continued taking an oral maintenance dose (0.5 mg, 1.0 mg, or 2.5 mg per day), and patients in the placebo group continued placebo for 60 days. The primary endpoint was the incidence of clinically significant major or minor bleeding according to the thrombolysis in myocardial infarction (TIMI) scale. Both investigators and patients were unaware of treatment allocation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00132912.257 patients were assigned to placebo and 773 to SCH 530348. The primary endpoint occurred in 2 (2%) of 129, 3 (3%) of 120, and 7 (4%) of 173 patients, respectively, in the SCH 530348 10 mg, 20 mg, and 40 mg groups compared with 5 (3%) of 151 patients in the placebo group (p=0.5786). TIMI major plus minor bleeding occurred in 3 (2%) of 136, 5 (4%) of 139, and 4 (3%) of 138 patients given SCH 530348 0.5 mg, 1.0 mg, and 2.5 mg once per day, respectively (p=0.7561).Oral SCH 530348 was generally well tolerated and did not cause increased TIMI bleeding, even when administered concomitantly with aspirin and clopidogrel. Further testing in phase III trials to accurately define the safety and efficacy of SCH 530348 is warranted.

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Published In

Lancet (London, England)

DOI

EISSN

1474-547X

ISSN

0140-6736

Publication Date

March 2009

Volume

373

Issue

9667

Start / End Page

919 / 928

Related Subject Headings

  • Receptors, Thrombin
  • Pyridines
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Lactones
  • Humans
  • Hemorrhage
  • General & Internal Medicine
 

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Becker, R. C., Moliterno, D. J., Jennings, L. K., Pieper, K. S., Pei, J., Niederman, A., … TRA-PCI Investigators, . (2009). Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet (London, England), 373(9667), 919–928. https://doi.org/10.1016/s0140-6736(09)60230-0
Becker, Richard C., David J. Moliterno, Lisa K. Jennings, Karen S. Pieper, Jinglan Pei, Alan Niederman, Khaled M. Ziada, et al. “Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study.Lancet (London, England) 373, no. 9667 (March 2009): 919–28. https://doi.org/10.1016/s0140-6736(09)60230-0.
Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, et al. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet (London, England). 2009 Mar;373(9667):919–28.
Becker, Richard C., et al. “Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study.Lancet (London, England), vol. 373, no. 9667, Mar. 2009, pp. 919–28. Epmc, doi:10.1016/s0140-6736(09)60230-0.
Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA, TRA-PCI Investigators. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet (London, England). 2009 Mar;373(9667):919–928.
Journal cover image

Published In

Lancet (London, England)

DOI

EISSN

1474-547X

ISSN

0140-6736

Publication Date

March 2009

Volume

373

Issue

9667

Start / End Page

919 / 928

Related Subject Headings

  • Receptors, Thrombin
  • Pyridines
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Lactones
  • Humans
  • Hemorrhage
  • General & Internal Medicine