Redesigning TRACER trial after TRITON

Victor L. Serebruany

Research output: Contribution to journalArticle

Abstract

Abstract Designing of smart clinical trials is critical for regulatory approval and future drug utilization. Importantly, trial design should be reconsidered if the interim analyses suggest unexpected harm, or conflicting results were yielded from the other trials within the same therapeutic area. With regard to antiplatelet agents, the perfect example is redesigning of the ongoing PRoFESS trial by eliminating aspirin from clopidogrel arm after the earlier MATCH trial results became available. The goal was to aseess the unchanged TRACER trial design in light of the evidence yielded from the earlier completed TRITON trial. TRACER was designed as a triple versus dual antiplatelet trial in NSTEMI patients with no previous long-term outcome data supporting such aggressive strategy. TRITON data represented dual versus dual antiplatelet therapy, and became available before TRACER enrollment starts revealing prasugrel front-loaded early vascular benefit predominantly in STEMI patients with the growing over time bleeding and cancer risks. Moreover, large prasugrel NSTEMI TRITON cohort exhibited trend towards excess mortality in experimental arm warning against aggressive TRACER design. The long-term TRITON results in general, and especially in the NSTEMI patients challenge unchanged TRACER trial design. Applying dual, rather than triple antiplatelet therapy protocol modification should be considered in TRACER to minimize bleeding, cancer, and non-cardiovascular death risks.

Original languageEnglish (US)
Article number20676
Pages (from-to)44-47
Number of pages4
JournalInternational Journal of Cardiology
Volume197
DOIs
StatePublished - Aug 5 2015

Fingerprint

clopidogrel
Drug Utilization
Bleeding Time
Platelet Aggregation Inhibitors
Aspirin
Blood Vessels
Neoplasms
Therapeutics
Clinical Trials
Hemorrhage
Mortality
Non-ST Elevated Myocardial Infarction
Prasugrel Hydrochloride
ST Elevation Myocardial Infarction

Keywords

  • Clinical trials
  • Outcomes
  • Prasugrel
  • Trial design
  • Vorapaxar

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Redesigning TRACER trial after TRITON. / Serebruany, Victor L.

In: International Journal of Cardiology, Vol. 197, 20676, 05.08.2015, p. 44-47.

Research output: Contribution to journalArticle

Serebruany, Victor L. / Redesigning TRACER trial after TRITON. In: International Journal of Cardiology. 2015 ; Vol. 197. pp. 44-47.
@article{4471c3b9299644dab907940dcbc9d076,
title = "Redesigning TRACER trial after TRITON",
abstract = "Abstract Designing of smart clinical trials is critical for regulatory approval and future drug utilization. Importantly, trial design should be reconsidered if the interim analyses suggest unexpected harm, or conflicting results were yielded from the other trials within the same therapeutic area. With regard to antiplatelet agents, the perfect example is redesigning of the ongoing PRoFESS trial by eliminating aspirin from clopidogrel arm after the earlier MATCH trial results became available. The goal was to aseess the unchanged TRACER trial design in light of the evidence yielded from the earlier completed TRITON trial. TRACER was designed as a triple versus dual antiplatelet trial in NSTEMI patients with no previous long-term outcome data supporting such aggressive strategy. TRITON data represented dual versus dual antiplatelet therapy, and became available before TRACER enrollment starts revealing prasugrel front-loaded early vascular benefit predominantly in STEMI patients with the growing over time bleeding and cancer risks. Moreover, large prasugrel NSTEMI TRITON cohort exhibited trend towards excess mortality in experimental arm warning against aggressive TRACER design. The long-term TRITON results in general, and especially in the NSTEMI patients challenge unchanged TRACER trial design. Applying dual, rather than triple antiplatelet therapy protocol modification should be considered in TRACER to minimize bleeding, cancer, and non-cardiovascular death risks.",
keywords = "Clinical trials, Outcomes, Prasugrel, Trial design, Vorapaxar",
author = "Serebruany, {Victor L.}",
year = "2015",
month = "8",
day = "5",
doi = "10.1016/j.ijcard.2015.06.020",
language = "English (US)",
volume = "197",
pages = "44--47",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Redesigning TRACER trial after TRITON

AU - Serebruany, Victor L.

PY - 2015/8/5

Y1 - 2015/8/5

N2 - Abstract Designing of smart clinical trials is critical for regulatory approval and future drug utilization. Importantly, trial design should be reconsidered if the interim analyses suggest unexpected harm, or conflicting results were yielded from the other trials within the same therapeutic area. With regard to antiplatelet agents, the perfect example is redesigning of the ongoing PRoFESS trial by eliminating aspirin from clopidogrel arm after the earlier MATCH trial results became available. The goal was to aseess the unchanged TRACER trial design in light of the evidence yielded from the earlier completed TRITON trial. TRACER was designed as a triple versus dual antiplatelet trial in NSTEMI patients with no previous long-term outcome data supporting such aggressive strategy. TRITON data represented dual versus dual antiplatelet therapy, and became available before TRACER enrollment starts revealing prasugrel front-loaded early vascular benefit predominantly in STEMI patients with the growing over time bleeding and cancer risks. Moreover, large prasugrel NSTEMI TRITON cohort exhibited trend towards excess mortality in experimental arm warning against aggressive TRACER design. The long-term TRITON results in general, and especially in the NSTEMI patients challenge unchanged TRACER trial design. Applying dual, rather than triple antiplatelet therapy protocol modification should be considered in TRACER to minimize bleeding, cancer, and non-cardiovascular death risks.

AB - Abstract Designing of smart clinical trials is critical for regulatory approval and future drug utilization. Importantly, trial design should be reconsidered if the interim analyses suggest unexpected harm, or conflicting results were yielded from the other trials within the same therapeutic area. With regard to antiplatelet agents, the perfect example is redesigning of the ongoing PRoFESS trial by eliminating aspirin from clopidogrel arm after the earlier MATCH trial results became available. The goal was to aseess the unchanged TRACER trial design in light of the evidence yielded from the earlier completed TRITON trial. TRACER was designed as a triple versus dual antiplatelet trial in NSTEMI patients with no previous long-term outcome data supporting such aggressive strategy. TRITON data represented dual versus dual antiplatelet therapy, and became available before TRACER enrollment starts revealing prasugrel front-loaded early vascular benefit predominantly in STEMI patients with the growing over time bleeding and cancer risks. Moreover, large prasugrel NSTEMI TRITON cohort exhibited trend towards excess mortality in experimental arm warning against aggressive TRACER design. The long-term TRITON results in general, and especially in the NSTEMI patients challenge unchanged TRACER trial design. Applying dual, rather than triple antiplatelet therapy protocol modification should be considered in TRACER to minimize bleeding, cancer, and non-cardiovascular death risks.

KW - Clinical trials

KW - Outcomes

KW - Prasugrel

KW - Trial design

KW - Vorapaxar

UR - http://www.scopus.com/inward/record.url?scp=84938511890&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84938511890&partnerID=8YFLogxK

U2 - 10.1016/j.ijcard.2015.06.020

DO - 10.1016/j.ijcard.2015.06.020

M3 - Article

VL - 197

SP - 44

EP - 47

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

M1 - 20676

ER -