Evidence map›Paper›PMID 36871000›Full record

Trial reportTrials2023

Effect of low-dose aspirin on urinary 11-dehydro-thromboxane B2 in the ASCEND (A Study of Cardiovascular Events iN Diabetes) randomized controlled trial.

Sarah Parish, Georgina Buck, Theingi Aung, Marion Mafham, Sarah Clark, Michael R Hill, Rory Collins, Louise Bowman, Jane Armitage, ASCEND Study Collaborative Group

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00135226 (A Study of Cardiovascular Events iN Diabetes - A Randomized 2x2 Factorial Study of Aspirin Versus Placebo, and of Omega-3 Fatty Acid Supplementation Versus Placebo, for Primary Prevention of Cardiovascular Events in People With Diabetes), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

NCT00135226 phase4active not recruitingnot on this map

A Study of Cardiovascular Events iN Diabetes - A Randomized 2x2 Factorial Study of Aspirin Versus Placebo, and of Omega-3 Fatty Acid Supplementation Versus Placebo, for Primary Prevention of Cardiovascular Events in People With Diabetes

TypeinterventionalSponsorUniversity of OxfordRan2005 to 2037Enrolled15,480ConditionsDiabetes MellitusArmsAspirin, Omega-3 Ethyl Esters, Placebo Aspirin, Placebo Omega-3 Ethyl Esters
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. 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

10 authors at 1 institution in 1 country.

Sarah Parish *MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK. sarah.parish@ndph.ox.ac.uk.ORCID http://orcid.org/0000-0003-3532-0832
Georgina Buck *Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Theingi Aung *Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Marion Mafham *Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Sarah ClarkClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Michael R HillMRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.
Rory CollinsClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Louise Bowman *MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.
Jane Armitage *MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.
ASCEND Study Collaborative Group
University of Oxford · GB

Funding

British Heart Foundation CH/1996001/9454British Heart Foundation PG/05/013/18296British Heart Foundation SP/03/002British Heart Foundation SP/08/010/25939British Heart Foundation SP/14/3/31114Medical Research Council MC_UU_00017/3Medical Research Council MC_UU_00017/5Medical Research Council MC_UU_12026/5
6 · The paper itself

Abstract

backgroundAspirin is widely used for cardioprotection with its antiplatelet effects due to the blocking of thromboxane A2 production. However, it has been suggested that platelet abnormalities in those with diabetes prevent adequate suppression with once daily aspirin.

methodsIn the ASCEND randomized double-blind trial of aspirin 100 mg once daily versus placebo in participants with diabetes but no history of cardiovascular disease, suppression was assessed by measuring 11-dehydro-thromboxane B2 excretion in urine (U-TXM) in a randomly selected sample of 152 participants (76 aspirin arm, 74 placebo arm), plus 198 (93 aspirin arm, 105 placebo arm) adherent to study drugs and selected to maximize the numbers ingesting their last tablet 12-24 h before urine sampling. U-TXM was assayed using a competitive ELISA assay in samples mailed a mean of 2 years after randomization, with time since taking last aspirin/placebo tablet recorded at the time of sample provision. Effective suppression (U-TXM < 1500 pg/mg creatinine) and percentage reductions in U-TXM by aspirin allocation were compared.

resultsIn the random sample, U-TXM was 71% (95% CI 64-76%) lower among aspirin vs placebo-allocated participants. Among adherent participants in the aspirin arm, U-TXM was 72% (95% CI 69-75%) lower than in the placebo arm and 77% achieved effective suppression overall. Suppression was similar among those who ingested their last tablet more than 12 h before urine sampling with levels in the aspirin arm 72% (95% CI 67-77%) lower than in the placebo arm and 70% achieving effective suppression.

conclusionsDaily aspirin significantly reduces U-TXM in participants with diabetes, including at 12-24 h after ingestion.

trial registrationISRCTN ISRCTN60635500. Registered on 1 Sept 2005; ClinicalTrials.gov NCT00135226. Registered on 24 Aug 2005.

Indexed as

Cardiovascular DiseasesDiabetes MellitusAspirinHumansThromboxane B211-dehydro-thromboxane B2AspirinThromboxane B211-Dehydro-thromboxane B2Daily low-dose aspirinDiabetesRandomized placebo-controlled trial

Identifiers

PMID36871000
PMCPMC9985834
OpenAlexW4323073614

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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.