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COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.

Publication ,  Journal Article
Vlachojannis, GJ; Vogel, RF; Wilschut, JM; Lemmert, ME; Delewi, R; Diletti, R; van Vliet, R; van der Waarden, N; Nuis, R-J; Paradies, V ...
Published in: Am Heart J
June 2020

BACKGROUND: Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y12 inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown. HYPOTHESIS: The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose. STUDY DESIGN: COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours. CONCLUSIONS: The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

June 2020

Volume

224

Start / End Page

10 / 16

Location

United States

Related Subject Headings

  • Treatment Outcome
  • ST Elevation Myocardial Infarction
  • Preoperative Period
  • Prasugrel Hydrochloride
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Middle Aged
  • Male
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Vlachojannis, G. J., Vogel, R. F., Wilschut, J. M., Lemmert, M. E., Delewi, R., Diletti, R., … Smits, P. C. (2020). COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial. Am Heart J, 224, 10–16. https://doi.org/10.1016/j.ahj.2020.03.005
Vlachojannis, Georgios J., Rosanne F. Vogel, Jeroen M. Wilschut, Miguel E. Lemmert, Ronak Delewi, Roberto Diletti, Ria van Vliet, et al. “COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.Am Heart J 224 (June 2020): 10–16. https://doi.org/10.1016/j.ahj.2020.03.005.
Vlachojannis GJ, Vogel RF, Wilschut JM, Lemmert ME, Delewi R, Diletti R, van Vliet R, van der Waarden N, Nuis R-J, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial. Am Heart J. 2020 Jun;224:10–16.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

June 2020

Volume

224

Start / End Page

10 / 16

Location

United States

Related Subject Headings

  • Treatment Outcome
  • ST Elevation Myocardial Infarction
  • Preoperative Period
  • Prasugrel Hydrochloride
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Middle Aged
  • Male
  • Humans
  • Female