Evidence map›Paper›PMID 26637834›Full record

Trial reportEuropean heart journal2016

Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome.

Matthew T Roe, Derek D Cyr, Debra Eckart, Phillip J Schulte, Michael A Morse, Kimberly L Blackwell, Neal E Ready, S Yousuf Zafar, Anne W Beaven, John H Strickler and 11 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00699998 (A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% 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.

NCT00699998 phase3completednot on this map

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

TypeinterventionalSponsorEli Lilly and CompanyRan2008 to 2012Enrolled9,326ConditionsAcute Coronary SyndromeArmsClopidogrel, Prasugrel, Commercially-available Aspirin
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. P2Y12 inhibitors: do they increase cancer risk?Annals of translational medicine · 2019
    Review
  10. Article
  11. 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

21 authors at 9 institutions in 5 countries.

Matthew T RoeDuke Clinical Research Institute, 2400 Pratt Street, Rm 7035, Durham, NC 27705, USA Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA matthew.roe@duke.edu.
Derek D CyrDuke Clinical Research Institute, 2400 Pratt Street, Rm 7035, Durham, NC 27705, USA.
Debra EckartDuke Clinical Research Institute, 2400 Pratt Street, Rm 7035, Durham, NC 27705, USA.
Phillip J SchulteDuke Clinical Research Institute, 2400 Pratt Street, Rm 7035, Durham, NC 27705, USA.
Michael A MorseDivision of Medicine - Oncology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Kimberly L BlackwellDivision of Medicine - Oncology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Neal E ReadyDivision of Medicine - Oncology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
S Yousuf ZafarDivision of Medicine - Oncology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Anne W BeavenDivision of Medicine - Oncology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
John H StricklerDivision of Medicine - Oncology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Jane E OnkenDivision of Gastroenterology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Kenneth J WintersEli Lilly and Company, Indianapolis, IN, USA.
Lisa HouterlootEli Lilly and Company, Indianapolis, IN, USA.
Dmitry ZamoryakhinDaiichi Sankyo Development Ltd., London, UK.
Stephen D WiviottBrigham and Women's Hospital/Harvard Medical School, Boston, MA, USA.
Harvey D WhiteAuckland City Hospital, Green Lane Cardiovascular Service, Auckland, New Zealand.
Dorairaj PrabhakaranCentre for Chronic Disease Control and Public Health Foundation of India, New Delhi, India.
Keith A A FoxBritish Heart Foundation Centre for Cardiovascular Sciences, University of Edinburgh, Edinburgh, UK.
Paul W ArmstrongDivision of Cardiology, University of Alberta, Edmonton, AB, Canada.
E Magnus OhmanDuke Clinical Research Institute, 2400 Pratt Street, Rm 7035, Durham, NC 27705, USA Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
TRILOGY ACS Investigators
Duke University · USClinical Research Institute · USEli Lilly (United States) · USAuckland City Hospital · NZBritish Heart Foundation · GBCentre for Chronic Disease Control · INDaiichi Sankyo (United Kingdom) · GBHarvard University · USUniversity of Alberta · CA

Funding

Statistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVIDIAN, MARIE, KOSOROK, MICHAEL R · 2010 to 2019
$21.3M
NCI NIH HHS P01 CA142538
6 · The paper itself

Abstract

aimsStudies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS. METHODS AND

resultsThe Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel. Median treatment exposure was 15 months. Cancer history and screening procedures were collected. Suspected non-benign neoplasm events were reported and adjudicated. The primary outcome was detection of new, non-benign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. Among 9240 participants who received ≥1 dose of study drug, 1.8% had a confirmed neoplasm event. The efficacy composite of cardiovascular death, myocardial infarction, or stroke occurred more frequently among those with a neoplasm event vs. those without (18.2 vs. 13.5%) as did Global Use of Strategies to Open Occluded Coronary Arteries severe/moderate bleeding (11.2 vs. 1.5%). Screening rates were substantially higher in North America and Western Europe/Scandinavia vs. other regions. Factors most strongly associated with detection of neoplasm events were older age, region, male sex, and current/recent smoking. Among the pre-specified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8 vs. 1.7%; HR = 1.04; 95% CI 0.77-1.42; P = 0.79).

conclusionsNeoplasm events were infrequent during long-term DAPT after ACS, were associated with differential cancer-screening practices across regions, and the frequency of neoplasm detection was similar with prasugrel vs. clopidogrel.

trial registrationClinicalTrials.gov identifier: NCT00699998.

Indexed as

Acute Coronary SyndromeAgedClopidogrelDrug Therapy, CombinationFemaleHemorrhageHumansLong-Term CareMaleNeoplasmsNon-ST Elevated Myocardial InfarctionPlatelet Aggregation InhibitorsPrasugrel HydrochlorideTiclopidineTreatment OutcomeClopidogrelPlatelet Aggregation InhibitorsPrasugrel HydrochlorideTiclopidineAcute coronary syndromeAdjudicationAntiplatelet drugsClinical trialClopidogrelNeoplasmPrasugrelSurveillance

Identifiers

PMID26637834
PMCPMC4720838
OpenAlexW2183039121

What Socratic holds

Textmetadata
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 Socratic graph.