Evidence map›Paper›PMID 31420787›Full record

Trial reportJournal of thrombosis and thrombolysis2019

Pharmacokinetic/pharmacodynamic assessment of a novel, pharmaceutical lipid-aspirin complex: results of a randomized, crossover, bioequivalence study.

Dominick J Angiolillo, Deepak L Bhatt, Frank Lanza, Byron Cryer, Jin-Fei Dong, Walter Jeske, Ronald R Zimmerman, Estela von Chong, Jayne Prats, Efthymios N Deliargyris and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thrombosis and thrombolysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.3field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Should We Use Aspirin or P2YCurrent atherosclerosis reports · 2024
    Review
  6. Article
  7. Using aspirin to prevent and treat cancer.Inflammopharmacology · 2024
    Review
  8. Article
  9. Review
  10. Review
  11. Antiplatelet therapy after percutaneous coronary intervention.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
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

11 authors at 7 institutions in 1 country.

Dominick J AngiolilloDivision of Cardiology, University of Florida College of Medicine, 655 West 8th street, Jacksonville, FL, 32209, USA. dominick.angiolillo@jax.ufl.edu.ORCID http://orcid.org/0000-0001-8451-2131
Deepak L BhattBrigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA, USA.
Frank LanzaHouston Institute for Clinical Research, Houston, TX, USA.
Byron CryerUniversity of Texas Southwestern Medical School, Dallas, TX, USA.
Jin-Fei DongDivision of Hematology, Department of Medicine, University of Washington, Member, BloodWorks NW Research Institute, Seattle, WA, USA.
Walter JeskeCardiovascular Research Institute, Loyola University Chicago Health Sciences Division, Maywood, IL, USA.
Ronald R ZimmermanPLx Pharma, Sparta, NJ, USA.
Estela von ChongPLx Pharma, Sparta, NJ, USA.
Jayne PratsElysis LLC, Carlisle, MA, USA.
Efthymios N DeliargyrisPLx Pharma, Sparta, NJ, USA.
Upendra Marathi7 Hills Pharma, Houston, TX, USA.
PLx Pharma (United States) · USBrigham and Women's Hospital · USHouston Institute for Clinical Research · USLoyola University Chicago · USThe University of Texas Southwestern Medical Center · USUniversity of Florida · USUniversity of Washington · US

Funding

GI safety and therapeutics of oil-based PC-NSAIDsR42DK063882 · NIDDK · PLX PHARMA, INC. · PI LICHTENBERGER, LENARD M · 2004 to 2010
$2.3M
National Institute of Diabetes and Digestive and Kidney Diseases R42DK063882NIDDK NIH HHS R42DK063882
6 · The paper itself

Abstract

Aspirin (acetylsalicylic acid, ASA) can lead to gastrointestinal mucosal injury through disruption of its protective phospholipid bilayer. A liquid formulation of a novel pharmaceutical lipid-aspirin complex (PL-ASA) was designed to prevent this disruption. We sought to determine the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of PL-ASA compared with immediate release aspirin (IR-ASA). In this active-control crossover study, 32 healthy volunteers were randomized to receive 1 of 2 dose levels (a single dose of 325 mg or 650 mg) of either PL-ASA or IR-ASA. After a 2-week washout period between treatment assignments, subjects received a single dose of the alternative treatment, at the same dose level. The primary objectives of the study were to assess, for PL-ASA and IR-ASA at 325 mg and 650 mg dose levels, PK and PD bioequivalence, and safety, over a 24-h period after administration of both drugs. PK parameters were similar for PL-ASA and IR-ASA, and met FDA-criteria for bioequivalence. Regarding PD, both drugs also showed C

Indexed as

AdultAspirinCross-Over StudiesDrug CarriersGastrointestinal TractHumansLipidsMiddle AgedMucous MembraneTherapeutic EquivalencyThromboxane B2Young AdultAspirinDrug CarriersLipidsThromboxane B2AspirinBioequivalencePharmacodynamicPharmacokineticPlatelet

Identifiers

PMID31420787
PMCPMC6800884
OpenAlexW2967547848

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.