Evidence map›Paper›PMID 28611833›Full record

ArticleInterventional neurology2017

Open-Label Phase I Clinical Study to Assess the Safety and Efficacy of Cilostazol in Patients Undergoing Internal Carotid Artery Stent Placement.

Ameer E Hassan, Haralabos Zacharatos, Mikayel Grigoryan, Wondwossen G Tekle, Amir Khan, Farhan Siddiq, Gustavo J Rodriguez, Ramachandra Tummala, Bharathi Jagadeesan, M Fareed K Suri and 1 more

Open access · bronzeAbstract read
In one paragraph

Article in Interventional neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 77% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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 9 institutions in 1 country.

Ameer E HassanValley Baptist Brain and Spine Network, University of Texas Health Science Center - San Antonio, Harlingen, TX, MN, USA.
Haralabos ZacharatosVassar Brothers Medical Center, Poughkeepsie, NY, MN, USA.
Mikayel GrigoryanGlendale Adventist Medical Center, Glendale, CA, MN, USA.
Wondwossen G TekleValley Baptist Brain and Spine Network, University of Texas Health Science Center - San Antonio, Harlingen, TX, MN, USA.
Amir KhanUCSF Fresno, Fresno, CA, MN, USA.
Farhan SiddiqHarris Methodist Hospital, Fort Worth, TX, MN, USA.
Gustavo J RodriguezTexas Tech, El Paso, TX, MN, USA.
Ramachandra TummalaUniversity of Minnesota Medical Center, Minneapolis, MN, MN, USA.
Bharathi JagadeesanUniversity of Minnesota Medical Center, Minneapolis, MN, MN, USA.
M Fareed K SuriCentracare health, St. Cloud, MN, MN, USA.
Adnan I QureshiZeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis, MN, USA.
The University of Texas Health Science Center at San Antonio · USUniversity of Minnesota Medical Center · USAdventist Health Glendale · USCalifornia State University, Fresno · USCentraCare Health System · USTexas Health Harris Methodist Hospital Fort Worth · USTexas Tech University · USUniversity of Minnesota · USVassar Brothers Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOne-month dual antiplatelet treatment, with aspirin and clopidogrel, following internal carotid artery stent placement is the current standard of care to prevent in-stent thrombosis. Cilostazol, an antiplatelet drug, has been demonstrated to have a safety profile comparable to aspirin and clopidogrel.

objectiveTo evaluate the safety and clinical efficacy of cilostazol and aspirin therapy following internal carotid artery stent placement up to 1 month postprocedure.

methodsA phase I open-label, nonrandomized two-center prospective study was conducted. All subjects received aspirin (325 mg/day) and cilostazol (200 mg/day) 3 days before extracranial stent placement. Two antiplatelet agents were continued for 1 month postprocedure followed by aspirin daily monotherapy. The primary efficacy end point was the 30-day composite occurrence of death, cerebral infarction, transient ischemic attack, and in-stent thrombosis. The primary safety end point was bleeding.

resultsTwelve subjects (mean age ± SD, 66 ± 12 years; 9 males) were enrolled and underwent internal carotid artery angioplasty and stent placement. None of the subjects who successfully followed the study protocol experienced any complications at the 1- and 3-month follow-ups. One patient had a protocol deviation due to concurrent use of enoxaparin (1 mg/kg twice daily) in addition to aspirin and cilostazol, resulting in a fatal symptomatic intracerebral hemorrhage following successful stent placement on postprocedure day 1. One patient discontinued cilostazol after the first dose secondary to dizziness.

conclusionThe use of cilostazol and aspirin for internal carotid artery stent placement appears to be safe, but protocol compliance needs to be emphasized.

Indexed as

AspirinCarotid stenosisCerebral infarctionCilostazolClopidogrelInternal carotid stent placementTransient ischemic attack

Identifiers

PMID28611833
PMCPMC5465720
OpenAlexW2560618684

What OpenQuestion holds

Textmetadata
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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.