Evidence map›Paper›PMID 31994703›Full record

Trial reportEuropean heart journal2020

Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes.

Robert F Storey, Paul A Gurbel, Jurrien Ten Berg, Corine Bernaud, George D Dangas, Jean-Marie Frenoux, Diana A Gorog, Abdel Hmissi, Vijay Kunadian, Stefan K James and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03384966 (A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
7.1field-weighted citation impact, top 2% 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.

NCT03384966 phase2completednot on this map

A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease

TypeinterventionalSponsorViatris Innovation GmbHRan2018 to 2018Enrolled346ConditionsStable Coronary Artery DiseaseArmsSelatogrel, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 77 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Dual Antiplatelet Therapy with Parenteral P2YJournal of cardiovascular development and disease · 2023
    Review
  16. Review
  17. Pretreatment with P2YJournal of clinical medicine · 2023
    Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 7 countries.

Robert F StoreyDepartment of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.
Paul A GurbelInova Heart and Vascular Institute, Falls Church, VA, USA.
Jurrien Ten BergDepartment of Cardiologie, St Antonius Hospital, Nieuwegein, Netherlands.
Corine BernaudIdorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
George D DangasDivision of Cardiology, Mount Sinai Hospital, New York, NY, USA.
Jean-Marie FrenouxIdorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
Diana A GorogUniversity of Hertfordshire, Hertfordshire, UK.
Abdel HmissiIdorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
Vijay KunadianFaculty of Medical Sciences, Newcastle University, Newcastle, UK.
Stefan K JamesDepartment of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Jean-Francois TanguayDepartment of Medicine, Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Canada.
Henry TranInova Heart and Vascular Institute, Falls Church, VA, USA.
Dietmar TrenkDepartment of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Mike UferIdorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
Pim Van der HarstDepartment of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Arnoud W J Van't HofDepartment of Cardiology, Maastricht University Medical Centre (MUMC), Maastricht, Netherlands.
Dominick J AngiolilloDivision of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
Idorsia (Switzerland) · CHAlaska Heart and Vascular Institute · USFreeman Hospital · GBMaastricht University Medical Centre · NLMontreal Heart Institute · CAMount Sinai Hospital · USSt. Antonius Ziekenhuis · NLUniversitäts-Herzzentrum Freiburg-Bad Krozingen · DEUniversity Medical Center Groningen · NLUniversity of Florida · USUniversity of Hertfordshire · GBUniversity of Sheffield · GBUppsala University · SE

Funding

British Heart Foundation CS/15/7/31679
6 · The paper itself

Abstract

aimsTo study the pharmacodynamics and pharmacokinetics of selatogrel, a novel P2Y12 receptor antagonist for subcutaneous administration, in patients with chronic coronary syndromes (CCS). METHODS AND

resultsIn this double-blind, randomized study of 345 patients with CCS on background oral antiplatelet therapy, subcutaneous selatogrel (8 mg, n = 114; or 16 mg, n = 115) was compared with placebo (n = 116) (ClinicalTrials.gov: NCT03384966). Platelet aggregation was assessed over 24 h (VerifyNow assay) and 8 h (light transmittance aggregometry; LTA). Pharmacodynamic responders were defined as patients having P2Y12 reaction units (PRU) <100 at 30 min post-dose and lasting ≥3 h. At 30 min post-dose, 89% of patients were responders to selatogrel 8 mg, 90% to selatogrel 16 mg, and 16% to placebo (P < 0.0001). PRU values (mean ± standard deviation) were 10 ± 25 (8 mg), 4 ± 10 (16 mg), and 163 ± 73 (placebo) at 15 min and remained <100 up to 8 h for both doses, returning to pre-dose or near pre-dose levels by 24 h post-dose. LTA data showed similarly rapid and potent inhibition of platelet aggregation. Selatogrel plasma concentrations peaked ∼30 min post-dose. Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%).

conclusionsSelatogrel was rapidly absorbed following subcutaneous administration in CCS patients, providing prompt, potent, and consistent platelet P2Y12 inhibition sustained for ≥8 h and reversible within 24 h. Further studies of subcutaneous selatogrel are warranted in clinical scenarios where rapid platelet inhibition is desirable.

Indexed as

Platelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsBlood PlateletsHumansOrganophosphonatesPlatelet AggregationPlatelet Function TestsPyrimidinesSyndromeOrganophosphonatesPlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsPyrimidinesselatogrelCoronary artery diseaseP2Y12 receptor antagonistPharmacodynamicsPharmacokineticsPlatelet aggregationSelatogrel

Identifiers

PMID31994703
PMCPMC7556746
OpenAlexW2984201945

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.