Evidence map›Paper›PMID 22470429›Full record

Trial reportPloS one2012

Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial.

Alejandro Macchia, Nicolás Laffaye, Pablo D Comignani, Elena Cornejo Pucci, Cecilia Igarzabal, Alejandra S Scazziota, Lourdes Herrera, Javier A Mariani, Julio C Bragagnolo, Hugo Catalano and 2 more

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

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00793754. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 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.

NCT00793754 phase4completed

Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People

Ran2009Enrolled30Registered outcomes2Posted comparisons0ConditionsDiabetes MellitusArmsAspirin, Aspirin + Atorvastatin, Atorvastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Effect of atorvastatin on testosterone levels.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Statins for primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2014
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Statins and Hemostasis: Therapeutic Potential Based on Clinical Evidence.Advances in experimental medicine and biology · 2023
    Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. 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

12 authors at 5 institutions in 2 countries.

Alejandro MacchiaDepartment of Medicine, Hospital Alemán, Buenos Aires, Argentina. macchia@negrisud.it
Nicolás Laffaye
Pablo D Comignani
Elena Cornejo Pucci
Cecilia Igarzabal
Alejandra S Scazziota
Lourdes Herrera
Javier A Mariani
Julio C Bragagnolo
Hugo Catalano
Gianni Tognoni
Antonio Nicolucci
Hospital Alemán · ARCentro de Educación Médica e Investigaciones Clínicas Norberto Quirno · ARMario Negri Sud Foundation · ITUniversity of Buenos Aires · ARHospital Ramos Mejía · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG) among patients with type II diabetes mellitus and no previous cardiovascular events. METHODOLOGY/PRINCIPAL

findingsProspective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks), assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018). On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716). The effects of treatments on measurements of TG using other agonists were consistent. CONCLUSIONS/SIGNIFICANCE: While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG.

trial registrationClinicalTrials.gov NCT00793754.

Indexed as

Cardiovascular DiseasesAnticholesteremic AgentsAspirinAtorvastatinDiabetes Mellitus, Type 2Double-Blind MethodFemaleFibrinolytic AgentsHeptanoic AcidsHumansMaleMiddle AgedProspective StudiesPyrrolesRisk FactorsThrombinAnticholesteremic AgentsAspirinAtorvastatinFibrinolytic AgentsHeptanoic AcidsPyrrolesThrombin

Identifiers

PMID22470429
PMCPMC3314656
OpenAlexW2007201417

What OpenQuestion holds

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LicenceCC BY
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.