Evidence map›Paper›PMID 25523054›Full record

Trial reportStroke2015

Recombinant tissue-type plasminogen activator plus eptifibatide versus recombinant tissue-type plasminogen activator alone in acute ischemic stroke: propensity score-matched post hoc analysis.

Opeolu Adeoye, Heidi Sucharew, Jane Khoury, Thomas Tomsick, Pooja Khatri, Yuko Palesch, Pamela A Schmit, Arthur M Pancioli, Joseph P Broderick, CLEAR-ER, IMS III, and ALIAS Part 2 Investigators

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Acute Treatment of Stroke (Except Thrombectomy).Current neurology and neuroscience reports · 2018
    Review
  9. Interpretation of Brain CT Scans in the Field by Critical Care Physicians in a Mobile Stroke Unit.Journal of neuroimaging : official journal of the American Society of Neuroimaging · 2018
    Article
  10. Review
  11. Review
  12. 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

10 authors at 2 institutions in 1 country.

Opeolu AdeoyeFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.). Opeolu.Adeoye@uc.edu.
Heidi SucharewFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
Jane KhouryFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
Thomas TomsickFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
Pooja KhatriFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
Yuko PaleschFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
Pamela A SchmitFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
Arthur M PancioliFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
Joseph P BroderickFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.K., P.A.S., A.M.P., J.P.B.); Departments of Emergency Medicine (O.A., P.A.S., A.M.P.), Neurosurgery (O.A.), Radiology (T.T.), and Neurology (P.K., J.P.B.), University of Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, OH (H.S., J.K.); and Division of Biostatistics, Medical University of South Carolina, Charleston, SC (Y.P.).
CLEAR-ER, IMS III, and ALIAS Part 2 Investigators
Cincinnati Children's Hospital Medical Center · USUniversity of Cincinnati · US

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI HEUBI, JAMES E., KISSELA, BRETT M · 2015 to 2024
$37.5M
Interventional Management of Stroke Study (IMS III)U01NS052220 · NINDS · UNIVERSITY OF CINCINNATI · PI BRODERICK, JOSEPH PAUL · 2005 to 2012
$21.9M
THE RELATIONSHIP OF SERUM PROTEINS TO STROKE SEVERITYP50NS044283 · NINDS · UNIVERSITY OF CINCINNATI · PI FLATHERY, MATHEW · 2002 to 2012
$17.1M
Cincinnati Center for Clinical and Translational Sciences and TrainingUL1TR000077 · NCATS · UNIVERSITY OF CINCINNATI · PI HEUBI, JAMES E. · 2012 to 2014
$9.9M
The ALIAS StudyU01NS054630 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI PALESCH, YUKO Y · 2005 to 2010
$6.9M
Interventional Management of Stroke Phase III Trial - SDCCU01NS077304 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI PALESCH, YUKO Y · 2011 to 2013
$1.4M
NCATS NIH HHS UL1 TR000077NCATS NIH HHS UL1 TR001425NINDS NIH HHS P50 NS044283NINDS NIH HHS U01 NS052220NINDS NIH HHS U01NS052220NINDS NIH HHS U01 NS054630NINDS NIH HHS U01NS054630NINDS NIH HHS U01 NS077304NINDS NIH HHS U01NS077304
6 · The paper itself

Abstract

background and purposeThe Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER) trial demonstrated safety of recombinant tissue-type plasminogen activator (r-tPA) plus eptifibatide in acute ischemic stroke (AIS). CLEAR-ER randomized AIS patients (5:1) to 0.6 mg/kg r-tPA plus eptifibatide versus standard r-tPA (0.9 mg/kg). Interventional Management of Stroke III randomized AIS patients to r-tPA plus endovascular therapy versus standard r-tPA. Albumin in Acute Stroke Part 2 randomized patients to albumin±r-tPA versus saline±r-tPA. Our aim was to compare outcomes in CLEAR-ER combination arm patients to propensity score-matched r-tPA only subjects in Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III.

methodsThe primary outcome was 90-day severity-adjusted modified Rankin score (mRS) dichotomization based on baseline National Institutes of Health Stroke Scale. Secondary outcomes were 90-day mRS dichotomization as excellent (mRS, 0-1); mRS dichotomization as favorable (mRS, 0-2); and nonparametric analysis of the ordinal mRS.

resultsEighty-five combination arm CLEAR-ER subjects were matched with 169 Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III trials' r-tPA only patients (controls). Median age in CLEAR-ER and control subjects was 68years; median National Institutes of Health Stroke Scale in the CLEAR-ER subjects was 11 and in control subjects 12. At 90 days, CLEAR-ER subjects had a nonsignificantly greater proportion of patients with favorable outcomes (45% versus 36%; unadjusted relative risks, 1.24; 95% confidence intervals, 0.91-1.69; P=0.18). Secondary outcomes were 52% versus 34% excellent outcomes (relative risks, 1.51; 95% confidence intervals, 1.13-2.02; P=0.007); 60% versus 53% favorable outcome (relative risks, 1.13; 95% confidence intervals, 0.90-1.41; P=0.31); and ordinal Cochran-Mantel-Haenszel P=0.10.

conclusionr-tPA plus eptifibatide showed a favorable direction of effect that was consistent across multiple approaches for AIS outcome evaluation. A phase III trial to establish the efficacy of r-tPA plus eptifibatide for improving AIS outcomes is warranted.

Indexed as

Propensity ScoreAdultAgedAged, 80 and overBrain IschemiaDouble-Blind MethodDrug Therapy, CombinationEptifibatideFemaleFibrinolytic AgentsHumansMaleMiddle AgedPeptidesPlatelet Aggregation InhibitorsRecombinant ProteinsEptifibatideFibrinolytic AgentsPeptidesPlatelet Aggregation InhibitorsRecombinant ProteinsTissue Plasminogen Activatorclinical trialeptifibatidetissue-type plasminogen activator

Identifiers

PMID25523054
PMCPMC4308493
OpenAlexW2096981741

What OpenQuestion holds

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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.