Evidence map›Paper›PMID 32066489›Full record

ArticleTrials2020

Ticagrelor and preconditioning in patients with stable coronary artery disease (TAPER-S): a randomized pilot clinical trial.

D D'Amario, A Restivo, A M Leone, R Vergallo, S Migliaro, F Canonico, M Galli, C Trani, F Burzotta, C Aurigemma and 12 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 NCT02701140 (Ticagrelor And PrEconditioning in Patients With coronaRy Artery diSease), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 17% 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.

NCT02701140 phase2 / phase3completednot on this map

Ticagrelor And PrEconditioning in Patients With coronaRy Artery diSease

TypeinterventionalSponsorItalo PortoRan2016 to 2020Enrolled58ConditionsMyocardial IschemiaArmsCoronary stenting, intracoronary ECG recording, Coronary Flow reserve, Index of Microcirculatory Resistance, Fractional Flow Reserve
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
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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

22 authors at 5 institutions in 2 countries.

D D'AmarioFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
A RestivoFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
A M LeoneFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
R VergalloFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
S MigliaroFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
F CanonicoFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
M GalliFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
C TraniFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
F BurzottaFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
C AurigemmaFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
G NiccoliFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
A BuffonFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
R A MontoneFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
A FlexFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
F FranceschiFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
G TinelliFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
U LimbrunoDipartimento Cardio neuro vascolare, Azienda USL Toscana Sud-est, Ospedale di Grosseto, Grosseto, Italy.
F FranceseFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
I CeccarelliFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy.
J A BorovacDepartment of Pathophysiology, University of Split School of Medicine (USSM) and University Hospital Center Split (UHC Split), Split, Croatia.
I PortoOspedale Policlinico San Martino IRCCS, Università degli Studi di Genova, Genoa, Italy. italo.porto@gmail.com.
F CreaFondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Largo Agostino Gemelli 8, 00168, Rome, Italy. filippo.crea@unicatt.it.
Agostino Gemelli University Polyclinic · ITUniversità Cattolica del Sacro Cuore · ITOspedale Misericordia - Grosseto · ITUniversity of Genoa · ITUniversity of Split · HR

Funding

AstraZeneca SpA POR-TAP-16-007
6 · The paper itself

Abstract

backgroundTicagrelor is a reversibly binding, direct-acting, oral, P

methodsTo determine whether ticagrelor can trigger ischemic preconditioning and influence microvascular function, we designed this prospective, open-label, pilot study that enrolled patients with stable multivessel CAD requiring staged, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI). Participants will be randomized in 1:1 ratios either to ticagrelor (loading dose (LD) 180 mg, maintenance dose (MD) 90 mg bid) or to clopidogrel (LD 600 mg, MD 75 mg) from 3 to 1 days before the scheduled PCI. The PCI operators will be blinded to the randomization arm. The primary endpoint is the delta (difference) between ST segment elevations (in millimeters, mm) as assessed by intracoronary electrocardiogram (ECG) during the two-step sequential coronary balloon inflation in the culprit vessel. Secondary endpoints are 1) changes in coronary flow reserve (CFR), index of microvascular resistance (IMR), and FFR measured in the culprit vessel and reference vessel at the end of PCI, and 2) angina score during inflations. This study started in 2018 with the aim of enrolling 100 patients. Based on the rate of negative FFR up to 30% and a drop-out rate up to 10%, we expect to detect an absolute difference of 4 mm among the study arms in the mean change of ST elevation following repeated balloon inflations. All study procedures were reviewed and approved by the Ethical Committee of the Catholic University of Sacred Heart. DISCUSSION: Ticagrelor might improve ischemia tolerance and microvascular function compared to clopidogrel, and these effects might translate to better long-term clinical outcomes.

trial registrationEudraCT No. 2016-004746-28. No. NCT02701140.  TRIAL STATUS: Information provided in this manuscript refers to the definitive version (n. 3.0) of the study protocol, dated 31 October 2017, and includes all protocol amendments. Recruitment started on 18 September 2018 and is currently ongoing. The enrollment is expected to be completed by the end of 2019. TRIAL SPONSOR: Fondazione Policlinico Universitario A. Gemelli - Roma, Polo di Scienze Cardiovascolari e Toraciche, Largo Agostino Gemelli 8, 00168 Rome, Italy.

Indexed as

AdolescentAdultAgedClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicClopidogrelCoronary Artery DiseaseCoronary VesselsFemaleFractional Flow Reserve, MyocardialHumansIschemic Preconditioning, MyocardialMaleMicrovesselsMiddle AgedMyocardial Reperfusion InjuryClopidogrelPurinergic P2Y Receptor AntagonistsTicagrelorAdenosineAnginaClopidogrelFractional flow reserveIntracoronary electrocardiographyIschemic preconditioningMicrovascular dysfunctionMicrovascular functionMicrovascular resistanceTicagrelor

Identifiers

PMID32066489
PMCPMC7027127
OpenAlexW3011047329

What OpenQuestion holds

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LicenceCC BY
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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.