Evidence map›Paper›PMID 24803100›Full record

Trial reportBritish journal of clinical pharmacology2014

Interaction of clopidogrel and statins in secondary prevention after cerebral ischaemia - a randomized, double-blind, double-dummy crossover study.

Timo Siepmann, Denise Heinke, Jessica Kepplinger, Kristian Barlinn, Siegmund Gehrisch, Xina Grählert, Uta Schwanebeck, Heinz Reichmann, Volker Puetz, Ulf Bodechtel and 1 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 29% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

11 authors at 4 institutions in 1 country.

Timo SiepmannDepartment of Neurology, Dresden University of Technology, Dresden, Germany.
Denise Heinke
Jessica Kepplinger
Kristian Barlinn
Siegmund Gehrisch
Xina Grählert
Uta Schwanebeck
Heinz Reichmann
Volker Puetz
Ulf Bodechtel
Georg Gahn
TU Dresden · DEHochschule für Technik und Wirtschaft Dresden – University of Applied Sciences · DEUniversity Hospital Carl Gustav Carus · DEStädtisches Klinikum Karlsruhe · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsVariability in responsiveness to clopidogrel is a clinical problem in secondary prevention after cerebral ischaemia which has been suggested to be linked to competitive metabolization of clopidogrel and cytochrome P450 (CYP) 3A4-oxidated statins such as simvastatin. We assessed the hypothesis that simvastatin, in contrast to CYP 2C9-metabolized fluvastatin, reduces clopidogrel-mediated platelet inhibition.

methodsWe performed a randomized, double-blind, double-dummy, two period crossover study in 13 patients with cerebral ischaemia (8F, 5 M), aged 64.1 ± 8.0 years (mean ± SD). After a 14 day period in which all patients received 75 mg clopidogrel day(-1) , patients additionally received either 20 mg simvastatin day(-1) or 80 mg fluvastatin day(-1) for 14 days. Regimens were crossed over after a 14 day wash-out period and switched regimens were continued for another 14 days. Platelet aggregation, clopidogrel active metabolite (CAM) plasma concentrations and routine laboratory parameters including prothrombin time (PT) Quick percent value were assessed at baseline and following each treatment phase.

resultsClopidogrel reduced platelet aggregation in all patients as expected. Platelet aggregation and CAM plasma concentrations were unaltered when simvastatin or fluvastatin was added to clopidogrel. Simvastatin decreased PT Quick percent value (decrease from 109 ± 10.5% to 103 ± 11%, P < 0.05) when combined with clopidogrel but there was no such change following treatment with fluvastatin and clopidogrel.

conclusionsOur data indicate that treatment with CYP 3A4-metabolized simvastatin does not jeopardize clopidogrel-mediated inhibition of platelet aggregation. After co-administration of simvastatin and clopidogrel we observed a decrease in the PT Quick percent value which could be due to simvastatin-induced reduction of activity of prothrombin fragment 1 + 2.

Indexed as

AgedBrain IschemiaClopidogrelCross-Over StudiesCytochrome P-450 CYP3ADouble-Blind MethodDrug InteractionsDrug Therapy, CombinationFatty Acids, MonounsaturatedFemaleFluvastatinHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIndolesMaleMiddle AgedClopidogrelCYP3A4 protein, humanCytochrome P-450 CYP3AFatty Acids, MonounsaturatedFluvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsIndolesPlatelet Aggregation InhibitorsSimvastatinTiclopidineclopidogrelCYP 3A4fluvastatinplatelet aggregationsimvastatin

Identifiers

PMID24803100
PMCPMC4243880
OpenAlexW1694855869

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.