Evidence map›Paper›PMID 33234137›Full record

ArticleTrials2020

Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial.

Giuseppe Tarantini, Marco Mojoli, Ferdinando Varbella, Roberto Caporale, Stefano Rigattieri, Giuseppe Andò, Plinio Cirillo, Simona Pierini, Andrea Santarelli, Paolo Sganzerla and 25 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02618837 (Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non ST Elevated acUte Coronary Syndromes With Initial Invasive Indication), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 44% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02618837 phase4unknown statusnot on this map

Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non ST Elevated acUte Coronary Syndromes With Initial Invasive Indication

TypeinterventionalSponsorUniversity of PadovaRan2015 to 2022Enrolled2,520ConditionsUnstable Angina or Non ST Elevated Myocardial InfarctionArmsDownstream strategy, Upstream strategy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Highlights from the European society of cardiology congress 2020.Journal of thrombosis and thrombolysis · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors at 20 institutions in 2 countries.

Giuseppe TarantiniDepartment of Cardiac, Thoracic, and Vascular Sciences and Public Health, Policlinico Universitario, University of Padova, Via Giustiniani 2, 35128, Padova, Italy. giuseppe.tarantini.1@gmail.com.
Marco MojoliOspedale Santa Maria degli Angeli, Pordenone, Italy.ORCID http://orcid.org/0000-0002-6851-5946
Ferdinando VarbellaOspedali Riuniti, Rivoli, Italy.
Roberto CaporaleOspedale Civile dell'Annunziata, Cosenza, Italy.
Stefano RigattieriSandro Pertini Hospital, Rome, Italy.
Giuseppe AndòAzienda Ospedaliera Universitaria Policlinico "Gaetano Martino", Messina, Italy.
Plinio CirilloUniversity of Naples Federico II, Naples, Italy.
Simona PieriniOspedale Bassini, Cinisello Balsamo, Italy.
Andrea SantarelliOspedale Infermi, Rimini, Italy.
Paolo SganzerlaHospital of Treviglio Caravaggio, Treviglio, Italy.
Nicoletta De CesarePoliclinico San Marco, Zingonia, Italy.
Ugo LimbrunoAzienda Ospedaliera Grosseto, Grosseto, Italy.
Alessandro LupiOspedale Universitario "Maggiore della Carità", Novara, Italy.
Roberto RicciOspedale S. Spirito, Rome, Italy.
Carlo CernettiOspedale di Treviso ULSS 2, Treviso, Italy.
Luca FaveroOspedale di Treviso ULSS 2, Treviso, Italy.
Francesco SaiaUniversity Hospital of Bologna Sant'Orsola-Malpighi, Bologna, Italy.
Loris RonconHospital Santa Maria della Misericordia, Rovigo, Italy.
Valeria GasparettoCasa di Cura Pederzoli, Peschiera, Italy.
Marco FerliniIRCCS Policlinico San Matteo, Pavia, Italy.
Federico RoncoOspedale dell'Angelo, Mestre, Italy.
Luca FerriA.O. Ospedale di Lecco, Lecco, Italy.
Daniela TrabattoniCentro Cardiologico Monzino, Milan, Italy.
Alessandra RussoSant'Antonio Abate Hospital, Gallarate, Italy.
Vincenzo GuiducciAO-IRCCS Santa Maria Nuova, Reggio Emilia, Italy.
Carlo PenzoAzienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Ferrara, Italy.
Fabio TarantinoMorgagni-Pierantoni Hospital, Forlì, Italy.
Ciro MauroAntonio Cardarelli Hospital, Naples, Italy.
Alfredo MarcheseAnthea Hospital, Bari, Italy.
Battistina CastiglioniASST Sette Laghi, Varese, Italy.
Alessio La MannaUniversity Hospital Vittorio Emanuele, Catania, Italy.
Matteo MartinatoDepartment of Cardiac, Thoracic, and Vascular Sciences and Public Health, Policlinico Universitario, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
Dario GregoriDepartment of Cardiac, Thoracic, and Vascular Sciences and Public Health, Policlinico Universitario, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
Dominick J AngiolilloDivision of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
Giuseppe MusumeciDivision of Cardiology, Azienda Sanitaria Ospedaliera Ordine Mauriziano, Torino, Italy.
University of Padua · ITAULSS 2 Marca Trevigiana · ITAlessandro Manzoni Hospital · ITANT Foundation Italy Onlus · ITA. O. Ordine Mauriziano di Torino · ITArcispedale Sant'Anna · ITAzienda Ospedaliera Santa Maria Degli Angeli · ITAzienda Ospedaliera Sant’Antonio Abate di Gallarate · ITAzienda Ospedaliera Treviglio · ITAzienda Ospedaliera Universitaria Policlinico "G. Martino" · ITAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · ITAziende Socio Sanitarie Territoriale dei Sette LaghiCentro Cardiologico Monzino · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITIRCCS Policlinico San Donato · ITOspedale Annunziata di Cosenza · ITOspedale Antonio Cardarelli · ITOspedale Bassini · ITOspedale dell' Angelo · ITOspedale di Rivoli · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors-ticagrelor and prasugrel-currently recommended by the guidelines. STUDY

designDUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings.

conclusionsThe DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed.

trial registrationClinicalTrials.gov NCT02618837 . Registered on 1 December 2015.

Indexed as

Acute Coronary SyndromePercutaneous Coronary InterventionDrug Administration ScheduleHumansMulticenter Studies as TopicPrasugrel HydrochloridePurinergic P2Y Receptor AntagonistsRandomized Controlled Trials as TopicTicagrelorTreatment OutcomePrasugrel HydrochloridePurinergic P2Y Receptor AntagonistsTicagrelorBleedingIschemiaNon-ST elevation acute coronary syndromeOral P2Y12 inhibitorsRandomized clinical trial

Identifiers

PMID33234137
PMCPMC7686679
OpenAlexW3110516327

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.