Evidence map›Paper›PMID 26243231›Full record

Trial reportStroke2015

Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue-Type Plasminogen Activator in Acute Ischemic Stroke-Full Dose Regimen Stroke Trial.

Opeolu Adeoye, Heidi Sucharew, Jane Khoury, Achala Vagal, Pamela A Schmit, Irene Ewing, Steven R Levine, Stacie Demel, Bryan Eckerle, Brian Katz and 6 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
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. It is linked to trial NCT01977456 (Phase 2 The Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Full Dose Regimen), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01977456 phase2completednot on this map

Phase 2 The Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Full Dose Regimen(CLEAR-FDR)

TypeinterventionalSponsorArthur PancioliRan2013 to 2015Enrolled27ConditionsStroke, Brain InfarctionArmsEptifibatide
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Drip and ship in patients with acute ischemic stroke: a narrative review.Therapeutic advances in neurological disorders · 2025
    Review
  8. Review
  9. Antiplatelet Use in Ischemic Stroke.The Annals of pharmacotherapy · 2022
    Review
  10. Article
  11. Review
  12. The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods.International journal of stroke : official journal of the International Stroke Society · 2021
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. 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

16 authors.

Opeolu AdeoyeFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.). Opeolu.Adeoye@uc.edu.
Heidi SucharewFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Jane KhouryFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Achala VagalFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Pamela A SchmitFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Irene EwingFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Steven R LevineFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Stacie DemelFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Bryan EckerleFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Brian KatzFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Dawn KleindorferFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Brian StettlerFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Daniel WooFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Pooja KhatriFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Joseph P BroderickFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).
Arthur M PancioliFrom the University of Cincinnati Neuroscience Institute, OH (O.A., P.A.S., I.E., S.D., B.E., B.K., D.K., B.S., D.W., P.K., J.P.B., A.M.P.); Departments of Emergency Medicine (P.A.S., I.E., B.S., A.M.P.), Neurosurgery (O.A.), Radiology (A.V.), and Neurology (S.D., B.E., B.K., D.K., D.W., 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 Departments of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY (S.R.L.).

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
THE RELATIONSHIP OF SERUM PROTEINS TO STROKE SEVERITYP50NS044283 · NINDS · UNIVERSITY OF CINCINNATI · PI BRODERICK, JOSEPH PAUL · 2002 to 2012
$17.1M
Cerebrovascular Fellowship Training ProgramT32NS047996 · NINDS · UNIVERSITY OF CINCINNATI · PI Joseph Paul Broderick, Stacie Demel · 2006 to 2026
$3.7M
NCATS NIH HHS UL1 TR001425NINDS NIH HHS P50 NS044283NINDS NIH HHS T32 NS047996
6 · The paper itself

Abstract

background and purposeThe Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue-Type Plasminogen Activator (r-tPA; CLEAR) in Acute Ischemic Stroke (AIS) and CLEAR-Enhanced Regimen (CLEAR-ER) trials demonstrated safety of reduced dose r-tPA plus the glycoprotein 2b/3a inhibitor, eptifibatide, in AIS compared with r-tPA alone. The objective of the CLEAR-Full Dose Regimen (CLEAR-FDR) trial was to estimate the rate of symptomatic intracerebral hemorrhage (sICH) in AIS patients treated with the combination of full-dose r-tPA plus eptifibatide.

methodsCLEAR-FDR was a single-arm, prospective, open-label, multisite study. Patients aged 18 to 85 years treated with 0.9 mg/kg IV r-tPA within 3 hours of symptom onset were enrolled. After obtaining consent, eptifibatide (135 μg/kg bolus and 2-hour infusion at 0.75 μg/kg per minute) was administered. The primary end point was the proportion of patients who experienced sICH within 36 hours. An independent clinical monitor adjudicated if an sICH had occurred and an independent neuroradiologist reviewed all images. The stopping rule was 3 sICHs within the first 19 patients or 4 sICHs within 29 patients.

resultsFrom October 2013 to December 2014, 27 patients with AIS were enrolled. Median age was 73 years (range, 34-85; interquartile range, 65-80) and median National Institute of Health stroke scale score was 12 (range, 6-26; interquartile range, 9-16). One sICH (3.7%; 95% confidence interval, 0.7%-18%) was observed.

conclusionsThese results demonstrate comparable safety of full-dose r-tPA plus eptifibatide with historical rates of sICH with r-tPA alone and support proceeding with a phase 3 trial evaluating full-dose r-tPA combined with eptifibatide to improve outcomes after AIS.

Indexed as

AdultAgedAged, 80 and overBrain IschemiaCerebral HemorrhageDrug Therapy, CombinationEptifibatideFemaleFibrinolytic AgentsHumansMaleMiddle AgedPeptidesPlatelet Aggregation InhibitorsStrokeThrombolytic TherapyEptifibatideFibrinolytic AgentsPeptidesPlatelet Aggregation InhibitorsTissue Plasminogen Activatorclinical trialeptifibatidestroketissue-type plasminogen activator

Identifiers

PMID26243231
PMCPMC4550507

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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.