Evidence map›Paper›PMID 23414938›Full record

Trial reportJournal of hematology & oncology2013

A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease.

Ted Wun, Denis Soulieres, Andrew L Frelinger, Lakshmanan Krishnamurti, Enrico M Novelli, Abdullah Kutlar, Kenneth I Ataga, Charles L Knupp, Lillian E McMahon, John J Strouse and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of hematology & oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02824471 (Sickle Cell Disease), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT02824471 recruitingnot on this mapstarted 2014, after this paper: background citation

Sickle Cell Disease (SCD) Biochip': Towards a Simple and Reliable Way to Monitor Sickle Cell Disease

TypeobservationalSponsorUniversity Hospitals Cleveland Medical CenterRan2014 to 2028Enrolled100ConditionsSickle Cell DiseaseArmsSCD Group
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Platelet Aggregation Studies and Coagulation Profile in Sickle Cell Disease in Symptomatic and Steady State Patients.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2024
    Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Sickle cell vaso-occlusion: The dialectic between red cells and white cells.Experimental biology and medicine (Maywood, N.J.) · 2021
    Review
  12. Article
  13. Review
  14. Review
  15. Inflammation in sickle cell disease.Clinical hemorheology and microcirculation · 2018
    Article
  16. Review
  17. Article
  18. Sickle cell disease: an inherited thrombophilia.Hematology. American Society of Hematology. Education Program · 2016
    Review
  19. Review
  20. 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

16 authors at 11 institutions in 4 countries.

Ted WunUniversity of California, Davis Cancer Center, 4501 X St,, Ste, 3016, Sacramento, CA, 95817, USA. twun@ucdavis.edu
Denis Soulieres
Andrew L Frelinger
Lakshmanan Krishnamurti
Enrico M Novelli
Abdullah Kutlar
Kenneth I Ataga
Charles L Knupp
Lillian E McMahon
John J Strouse
Chunmei Zhou
Lori E Heath
Chuke E Nwachuku
Joseph A Jakubowski
Jeffrey S Riesmeyer
Kenneth J Winters
Eli Lilly (United States) · USUniversity of Pittsburgh · USAugusta University · USBoston Medical Center · USDaiichi-Sankyo (South Korea) · KREast Carolina University · USHarvard University Press · USJohns Hopkins Medicine · USUniversité de Montréal · CAUniversity of California, Davis · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlatelet activation has been implicated in the pathogenesis of sickle cell disease (SCD) suggesting antiplatelet agents may be therapeutic. To evaluate the safety of prasugrel, a thienopyridine antiplatelet agent, in adult patients with SCD, we conducted a double-blind, randomized, placebo-controlled study.

methodsThe primary endpoint, safety, was measured by hemorrhagic events requiring medical intervention. Patients were randomized to prasugrel 5 mg daily (n = 41) or placebo (n = 21) for 30 days. Platelet function by VerifyNow® P2Y12 and vasodilator-stimulated phosphoprotein assays at days 10 and 30 were significantly inhibited in prasugrel- compared with placebo-treated SCD patients.

resultsThere were no hemorrhagic events requiring medical intervention in either study arm. Mean pain rate (percentage of days with pain) and intensity in the prasugrel arm were decreased compared with placebo. However, these decreases did not reach statistical significance. Platelet surface P-selectin and plasma soluble P-selectin, biomarkers of in vivo platelet activation, were significantly reduced in SCD patients receiving prasugrel compared with placebo. In sum, prasugrel was well tolerated and not associated with serious hemorrhagic events.

conclusionsDespite the small size and short duration of this study, there was a decrease in platelet activation biomarkers and a trend toward decreased pain.

Indexed as

AdolescentAdultAnemia, Sickle CellBiomarkers, TumorCell Adhesion MoleculesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMicrofilament ProteinsMiddle AgedPainPhosphoproteinsPiperazinesPlatelet ActivationBiomarkers, TumorCell Adhesion MoleculesMicrofilament ProteinsPhosphoproteinsPiperazinesPlatelet Aggregation InhibitorsPrasugrel HydrochloridePurinergic P2Y Receptor AntagonistsThiophenesVasodilator-Stimulated Phosphoprotein

Identifiers

PMID23414938
PMCPMC3585853
OpenAlexW2139585567

What OpenQuestion holds

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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.