Trial reportJournal of thrombosis and thrombolysis2014

Pharmacodynamic effects of adjunctive high dose atorvastatin on double dose clopidogrel in patients with high on-treatment platelet reactivity depending on diabetes mellitus status.

Mario Leoncini, Anna Toso, Mauro Maioli, Dominick J Angiolillo, Betti Giusti, Rossella Marcucci, Rosanna Abbate, Francesco Bellandi

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of thrombosis and thrombolysis, 2014. The graph read 2 numbers from its abstract, feeding 2 cells of the map, but none could be read as for or against, so it casts no vote. It also reports 2 associations that do not count as treatment evidence, such as OR 1.07 (1.01 to 1.13) for kidney outcomes. It is linked to trial NCT03331666 (Impact of LDL-cholesterol Lowering on Platelet Activation), which is not on this map. Cited by 2 papers.

2numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

Read, but not usablea number the graph found but could not read as for or against

Kidney outcomesan association or prognostic statement, not a treatment comparison · dyslipidemia, t2dfeeds 2 cells of the map
OR 1.071.01 to 1.13p = 0.025
The baseline variables significantly associated with 30-day optimal response to high-dose clopidogrel were: atorvastatin treatment (OR = 7.5 [95% CI 1.19-47]; p = 0.032) in DM patients; PRU values (OR = 0.9 [95% CI 0.95-0.99]; p = 0.031) and creatinine clearance (OR = 1.07 [95% CI 1.008-1.13]; p = 0.025) in non-DM patients.
Kidney outcomesan association or prognostic statement, not a treatment comparison · dyslipidemia, t2dfeeds 2 cells of the map
OR 7.501.19 to 47.0p = 0.032
The baseline variables significantly associated with 30-day optimal response to high-dose clopidogrel were: atorvastatin treatment (OR = 7.5 [95% CI 1.19-47]; p = 0.032) in DM patients; PRU values (OR = 0.9 [95% CI 0.95-0.99]; p = 0.031) and creatinine clearance (OR = 1.07 [95% CI 1.008-1.13]; p = 0.025) in non-DM patients.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Antiplatelet & anticoagulant×kidney outcomes

No readable resultOpen on the map →What to test next →

No other readable study in this cell yet. This paper is the evidence.

Belief with this paperNo claim has been compiled for this cell yet.

Statins×kidney outcomes

No readable resultOpen on the map →What to test next →

4 readable studies in this cell: 0 favour the treatment, 3 find no difference, 1 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 1 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
1 · no effect
NCT023442907,769 enrolled · 2015
HR 0.600.14 to 2.51

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

NCT03331666 phase4terminatednot on this mapstarted 2018, after this paper: background citation

Impact of LDL-cholesterol Lowering on Platelet Activation

TypeinterventionalSponsorColumbia UniversityRan2018 to 2020Enrolled4ConditionsFamilial HypercholesterolemiaArmsEvolocumab
5 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Association ofFrontiers in pharmacology · 2018
    Article
  2. Review
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Mario LeonciniDivision of Cardiology, Misericordia e Dolce Hospital, Via Cavour, 2 Prato, Italy, leoncini.mario@tiscali.it.
Anna Toso
Mauro Maioli
Dominick J Angiolillo
Betti Giusti
Rossella Marcucci
Rosanna Abbate
Francesco Bellandi
Ospedale Misericordia e Dolce · ITUniversity of Florence · ITAzienda Ospedaliero-Universitaria Careggi · ITUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

Diabetes mellitus (DM) is associated with impaired platelet response to clopidogrel. In patients with high on-treatment platelet reactivity (HTPR) while on standard-dose clopidogrel, high-dose atorvastatin enhances the pharmacodynamic (PD) effects of double-dose clopidogrel. It is unknown if similar effects are achieved in patients with DM. This study compare the PD effects of high-dose atorvastatin associated with double dose clopidogrel in HTPR patients with and without DM undergoing elective percutaneous coronary intervention (PCI). This is a post hoc analysis of a prospective randomized PD study that compared double-dose (150 mg) clopidogrel associated with high-dose (80 mg) atorvastatin to double-dose clopidogrel alone in statin naïve patients with HTPR undergoing elective PCI. In this analysis, patients were divided in two groups according to DM (n = 27) and non-DM (n = 49) status. Platelet reactivity was evaluated immediately before PCI and at 30 days using the VerifyNow P2Y12 assay. HTPR was defined as P2Y12 reaction units (PRU) ≥235. Administering high-dose atorvastatin in addition to high-dose clipodogrel, the 30 days absolute PRU changes (106 ± 75 vs 100 ± 42, p = 0.7) and optimal response rates (83 vs 84%; p = 0.9) were similar in DM and non-DM patients. The baseline variables significantly associated with 30-day optimal response to high-dose clopidogrel were: atorvastatin treatment (OR = 7.5 [95% CI 1.19-47]; p = 0.032) in DM patients; PRU values (OR = 0.9 [95% CI 0.95-0.99]; p = 0.031) and creatinine clearance (OR = 1.07 [95% CI 1.008-1.13]; p = 0.025) in non-DM patients. High-dose atorvastatin significantly improved the PD effects of double-dose clopidogrel in DM patients with HTPR undergoing elective PCI.

Indexed as

Heptanoic AcidsPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPyrrolesAgedAtorvastatinClopidogrelDiabetes MellitusFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedPlatelet ActivationProspective StudiesThrombosisAtorvastatinClopidogrelHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPlatelet Aggregation InhibitorsPyrrolesTiclopidine

Identifiers

PMID23852152
OpenAlexW2016031125

What Socratic holds

Texttitle and abstract
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.