Study design and rationale for optimal antiplatelet pharmacotherapy guided by bedside genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST)

A prospective, open-label, randomised parallel-group multicentre trial (NCT01930773)

Łukasz Kołtowski, D. Aradi, Zenon Huczek, Mariusz Tomaniak, Dirk Sibbing, Krzysztof J. Filipiak, Janusz Kochman, Paweł Balsam, Grzegorz Opolski

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background and aim: High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications. Methods: The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the 2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI. Summary: The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping. Trial registration: ClinicalTrials.gov: NCT01930773.

Original languageEnglish
Pages (from-to)372-379
Number of pages8
JournalKardiologia Polska
Volume74
Issue number4
DOIs
Publication statusPublished - 2016

Fingerprint

clopidogrel
Percutaneous Coronary Intervention
Multicenter Studies
Drug Therapy
Blood Platelets
Alleles
Myocardial Infarction
Hemorrhage
Wounds and Injuries
Stents
Thrombosis
Therapeutics
Randomized Controlled Trials
Cross-Sectional Studies
Safety
Research

Keywords

  • Bedside testing
  • Clopidogrel
  • Cyp2c192 allele polymorphism
  • High platelet reactivity
  • Percutaneous coronary interventions
  • Prasugrel
  • Stable coronary artery disease
  • Therapy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Study design and rationale for optimal antiplatelet pharmacotherapy guided by bedside genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST) : A prospective, open-label, randomised parallel-group multicentre trial (NCT01930773). / Kołtowski, Łukasz; Aradi, D.; Huczek, Zenon; Tomaniak, Mariusz; Sibbing, Dirk; Filipiak, Krzysztof J.; Kochman, Janusz; Balsam, Paweł; Opolski, Grzegorz.

In: Kardiologia Polska, Vol. 74, No. 4, 2016, p. 372-379.

Research output: Contribution to journalArticle

@article{521671cbc21d4fdf98c2c0bdb08ff383,
title = "Study design and rationale for optimal antiplatelet pharmacotherapy guided by bedside genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): A prospective, open-label, randomised parallel-group multicentre trial (NCT01930773)",
abstract = "Background and aim: High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications. Methods: The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the ∗2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI. Summary: The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping. Trial registration: ClinicalTrials.gov: NCT01930773.",
keywords = "Bedside testing, Clopidogrel, Cyp2c192 allele polymorphism, High platelet reactivity, Percutaneous coronary interventions, Prasugrel, Stable coronary artery disease, Therapy",
author = "Łukasz Kołtowski and D. Aradi and Zenon Huczek and Mariusz Tomaniak and Dirk Sibbing and Filipiak, {Krzysztof J.} and Janusz Kochman and Paweł Balsam and Grzegorz Opolski",
year = "2016",
doi = "10.5603/KP.a2015.0172",
language = "English",
volume = "74",
pages = "372--379",
journal = "Kardiologia Polska",
issn = "0022-9032",
publisher = "Klinika Kardiologii CMKP",
number = "4",

}

TY - JOUR

T1 - Study design and rationale for optimal antiplatelet pharmacotherapy guided by bedside genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST)

T2 - A prospective, open-label, randomised parallel-group multicentre trial (NCT01930773)

AU - Kołtowski, Łukasz

AU - Aradi, D.

AU - Huczek, Zenon

AU - Tomaniak, Mariusz

AU - Sibbing, Dirk

AU - Filipiak, Krzysztof J.

AU - Kochman, Janusz

AU - Balsam, Paweł

AU - Opolski, Grzegorz

PY - 2016

Y1 - 2016

N2 - Background and aim: High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications. Methods: The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the ∗2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI. Summary: The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping. Trial registration: ClinicalTrials.gov: NCT01930773.

AB - Background and aim: High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications. Methods: The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the ∗2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI. Summary: The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping. Trial registration: ClinicalTrials.gov: NCT01930773.

KW - Bedside testing

KW - Clopidogrel

KW - Cyp2c192 allele polymorphism

KW - High platelet reactivity

KW - Percutaneous coronary interventions

KW - Prasugrel

KW - Stable coronary artery disease

KW - Therapy

UR - http://www.scopus.com/inward/record.url?scp=84963853481&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84963853481&partnerID=8YFLogxK

U2 - 10.5603/KP.a2015.0172

DO - 10.5603/KP.a2015.0172

M3 - Article

VL - 74

SP - 372

EP - 379

JO - Kardiologia Polska

JF - Kardiologia Polska

SN - 0022-9032

IS - 4

ER -