Evidence map›Paper›PMID 33327737›Full record

Trial reportJournal of the American Heart Association2021

Efficacy and Safety of Adjunctive Cilostazol to Clopidogrel-Treated Diabetic Patients With Symptomatic Lower Extremity Artery Disease in the Prevention of Ischemic Vascular Events.

Kallirroi Kalantzi, Nikolaos Tentolouris, Andreas J Melidonis, Styliani Papadaki, Michail Peroulis, Konstantinos A Amantos, George Andreopoulos, George I Bellos, Dimitrios Boutel, Magdalini Bristianou and 27 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06129526 (Study of the Effect of Eicosapentaenoic Acid), which is not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 12% 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.

NCT06129526 phase4unknown statusnot on this mapstarted 2023, after this paper: background citation

Study of the Effect of Eicosapentaenoic Acid (EPA) on Markers of Atherothrombosis in Patients With Type-2 Diabetes

TypeinterventionalSponsorUniversity of IoanninaRan2023 to 2024Enrolled450ConditionsDiabetes Type 2, Hypertriglyceridemia, Diabetes MellitusArmsEPAVasc, Corn Oil
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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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

37 authors at 14 institutions in 1 country.

Kallirroi KalantziAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
Nikolaos Tentolouris1st Department of Propaedeutic Internal Medicine Medical School National and Kapodistrian University of Athens Greece.
Andreas J MelidonisDiabetes Center Metropolitan Hospital Athens Greece.
Styliani PapadakiAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
Michail PeroulisAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
Konstantinos A AmantosDiabetes Center Metropolitan Hospital Athens Greece.
George AndreopoulosDiabetes Center Metropolitan Hospital Athens Greece.
George I BellosKoropi Health Center Attica Greece.
Dimitrios BoutelGeneral Hospital of Giannitsa Greece.
Magdalini BristianouDepartment of Internal Medicine General Hospital of Lamia Greece.
Dimitrios Chrisis3rd Internal Medicine Department and Diabetes Center General Hospital of Nikaia Athens Greece.
Nikolaos A DimitsikoglouAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
John DoupisAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
Chrysoula GeorgopoulouDiabetes Center Metropolitan Hospital Athens Greece.
Stergios A GkintikasDivision of Endocrinology and Metabolism and Diabetes Center First Department of Internal Medicine Medical School Aristotle University of ThessalonikiAHEPA University Hospital Thessaloniki Greece.
Styliani Iraklianou3rd Department of Internal Medicine Center General Hospital "Tzaneio," Piraeus Greece.
Κonstantinos Kanellas3rd Department of Internal Medicine Center General Hospital "Tzaneio," Piraeus Greece.
Kalliopi KotsaDivision of Endocrinology and Metabolism and Diabetes Center First Department of Internal Medicine Medical School Aristotle University of ThessalonikiAHEPA University Hospital Thessaloniki Greece.
Theocharis KoufakisDivision of Endocrinology and Metabolism and Diabetes Center First Department of Internal Medicine Medical School Aristotle University of ThessalonikiAHEPA University Hospital Thessaloniki Greece.
Maria KouroglouGeneral Regional Hospital of Mytilene Greece.
Anastasios G Koutsovasilis3rd Internal Medicine Department and Diabetes Center General Hospital of Nikaia Athens Greece.
Leonidas LanarasDepartment of Internal Medicine General Hospital of Lamia Greece.
Eirini Liouri3rd Internal Medicine Department and Diabetes Center General Hospital of Nikaia Athens Greece.
Charalampos LixouriotisHealth Center of Distomo Voiotia Greece.
Akrivi Lykoudi3rd Internal Medicine Department and Diabetes Center General Hospital of Nikaia Athens Greece.
Efthymia MandalakiAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
Evanthia Papageorgiou3rd Internal Medicine Department and Diabetes Center General Hospital of Nikaia Athens Greece.
Nikolaos PapanasSecond Department of Internal Medicine Democritus University of Thrace Alexandroupolis Greece.
Spyridon Rigas3rd Internal Medicine Department and Diabetes Center General Hospital of Nikaia Athens Greece.
Maria I StamatelatouInternal Medicine Clinic General Hospital of Sitia Crete Greece.
Ioannis TriantafyllidisAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
Aikaterini TrikkalinouDiabetes Center Metropolitan Hospital Athens Greece.
Aikaterini N TsoukaAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
Ourania ZacharopoulouDiabetes Center Metropolitan Hospital Athens Greece.
Christos ZoupasDiabetes Center Metropolitan Hospital Athens Greece.
Ioannis TsolakisVascular Surgery Department University of Patras Greece.
Alexandros D TselepisAtherothrombosis Research Center Laboratory of Biochemistry Department of Chemistry University of Ioannina Greece.
University of Ioannina · GRMetropolitan Hospital · GRKAT General Hospital of Attica · GRAristotle University of Thessaloniki · GRTechnological Educational Institute of Central Greece · GRTzaneion General Hospital · GRArgo (Greece) · GRDemocritus University of Thrace · GRGeneral Hospital of Nikea · GRNational and Kapodistrian University of Athens · GRPapageorgiou General Hospital · GRSotiria General Hospital · GRUniversity of Patras · GRVodafone (Greece) · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Type 2 diabetes mellitus is a risk factor for lower extremity arterial disease. Cilostazol expresses antiplatelet, anti-inflammatory, and vasodilator actions and improves the claudication intermittent symptoms. We investigated the efficacy and safety of adjunctive cilostazol to clopidogrel-treated patients with type 2 diabetes mellitus exhibiting symptomatic lower extremity arterial disease, in the prevention of ischemic vascular events and improvement of the claudication intermittent symptoms. Methods and Results In a prospective 2-arm, multicenter, open-label, phase 4 trial, patients with type 2 diabetes mellitus with intermittent claudication receiving clopidogrel (75 mg/d) for at least 6 months, were randomly assigned in a 1:1 ratio, either to continue to clopidogrel monotherapy, without receiving placebo cilostazol (391 patients), or to additionally receive cilostazol, 100 mg twice/day (403 patients). The median duration of follow-up was 27 months. The primary efficacy end point, the composite of acute ischemic stroke/transient ischemic attack, acute myocardial infarction, and death from vascular causes, was significantly reduced in patients receiving adjunctive cilostazol compared with the clopidogrel monotherapy group (sex-adjusted hazard ratio [HR], 0.468; 95% CI, 0.252-0.870;

Indexed as

Brain IschemiaCilostazolClopidogrelIntermittent ClaudicationMyocardial InfarctionAgedDiabetes Mellitus, Type 2Drug MonitoringDrug Therapy, CombinationFemaleHumansLower ExtremityMaleOutcome and Process Assessment, Health CarePlatelet Aggregation InhibitorsTreatment OutcomeCilostazolClopidogrelPlatelet Aggregation Inhibitorscilostazolclopidogrelcoronary artery diseasediabetes mellitusintermittent claudicationischemic stroke

Identifiers

PMID33327737
PMCPMC7955466
OpenAlexW3112442236

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.