Trial reportStroke2016
Selecting Patients for Intra-Arterial Therapy in the Context of a Clinical Trial for Neuroprotection.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Stroke, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02222714 (A Multi-center, Phase 2 Study Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC in Combination With tPA, Mechanical Thrombectomy or Both in Moderate to Severe Acute Ischemic Stroke), which is not on this map. Cited by 14 papers.
0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.8field-weighted citation impact, top 6% of its field
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.
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.
A Multi-center, Phase 2 Study Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC in Combination With tPA, Mechanical Thrombectomy or Both in Moderate to Severe Acute Ischemic Stroke
Who cites it
14 citing papers in PubMed, 20 citations in OpenAlex.
- Trial
- Analysis of brain edema in RHAPSODY.International journal of stroke : official journal of the International Stroke Society · 2024Article
- Review
- Selective cerebral cooling for acute ischemic stroke.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2020Article
- Seven-Year Experience From the National Institute of Neurological Disorders and Stroke-Supported Network for Excellence in Neuroscience Clinical Trials.JAMA neurology · 2020Article
- Optimizing functional outcome endpoints for stroke recovery studies.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2019Review
- Neuroprotection and vasculoprotection using genetically targeted protease-ligands.Brain research · 2019Article
- 3K3A-activated protein C blocks amyloidogenic BACE1 pathway and improves functional outcome in mice.The Journal of experimental medicine · 2019Article
- Treatment duration affects cytoprotective efficacy of positive allosteric modulation of α7 nAChRs after focal ischemia in rats.Pharmacological research · 2018Article
- Can adjunctive therapies augment the efficacy of endovascular thrombolysis? A potential role for activated protein C.Neuropharmacology · 2018Review
- Data Standardization and Quality Management.Translational stroke research · 2018Article
- The High Cost of Stroke and Stroke Cytoprotection Research.Translational stroke research · 2017Review
- Cytoprotective Drug-Tissue Plasminogen Activator Protease Interaction Assays: Screening of Two Novel Cytoprotective Chromones.Translational stroke research · 2017Article
- Stroke Cytoprotection: Can Repeating History with New Expectations Really Be the Path to Success in Stroke Research?Translational stroke research · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 1 institution in 1 country.
Patrick LydenFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.). lydenp@cshs.org.
Sara WeymerFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Chris CoffeyFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Merit CudkowiczFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Samantha BergFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Sarah O'BrienFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Marc FisherFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
E Clarke HaleyFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Pooja KhatriFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Jeff SaverFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Steven LevineFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Howard LevyFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Marilyn RymerFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Lawrence WechslerFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Ashutosh JadhavFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Elizabeth McNeilFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Salina WaddyFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Kent PryorFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); ZZ Biotech, LLC, Houston, TX (S.W., H.L., K.P.); Department of Biostatistics, University of Iowa, Iowa City (C.C., S.O.); Neurological Clinical Research Institute, Massachusetts General Hospital, Boston (M.C., S.B.); Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.F.); Department of Neurology, University of Virginia, Charlottesville (E.C.H.); Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.); Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (J.S.); Department of Neurology, State University of New York Downstate Medical Center, Brooklyn (S.L.); Department of Neurology, University of Kansas Hospital, Kansas City (M.R.); Department of Neurology, University of Pittsburgh Medical School, PA (L.W., A.J.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (E.M., S.W.).
Cedars-Sinai Medical Center · US
Funding
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical TrialU01NS077179 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI Merit E CUDKOWICZ, Aleksandar Videnovic · 2011 to 2026
$43.4MNetwork of Excellence in Neuroscience Clinical Trials (NEXT)-DCCU01NS077352 · NINDS · UNIVERSITY OF IOWA · PI CHRISTOPHER S. COFFEY · 2011 to 2026
$28.1MZZ-3K3A-201: Safety evaluation of 3K3A-APC in ischemic strokeU01NS088312 · NINDS · CEDARS-SINAI MEDICAL CENTER · PI LYDEN, PATRICK D · 2014 to 2017
$7.4MNINDS NIH HHS U01 NS077179NINDS NIH HHS U01 NS077352NINDS NIH HHS U01 NS088312
Abstract
background and purposeThe advent of intra-arterial neurothrombectomy (IAT) for acute ischemic stroke opens a potentially transformative opportunity to improve neuroprotection studies. Combining a putative neuroprotectant with recanalization could produce more powerful trials but could introduce heterogeneity and adverse event possibilities. We sought to demonstrate feasibility of IAT in neuroprotectant trials by defining IAT selection criteria for an ongoing neuroprotectant clinical trial.
methodsThe study drug, 3K3A-APC, is a pleiotropic cytoprotectant and may reduce thrombolysis-associated hemorrhage. The NeuroNEXT trial NN104 (RHAPSODY) is designed to establish a maximally tolerated dose of 3K3A-APC. Each trial site provided their IAT selection criteria. An expert panel reviewed site criteria and published evidence. Finally, the trial leadership designed IAT selection criteria.
resultsDerived selection criteria reflected consistency among the sites and comparability to published IAT trials. A protocol amendment allowing IAT (and relaxed age, National Institutes of Health Stroke Scale, and time limits) in the RHAPSODY trial was implemented on June 15, 2015. Recruitment before and after the amendment improved from 8 enrolled patients (601 screened, 1.3%) to 51 patients (821 screened, 6.2%; odds ratio [95% confidence limit] of 4.9 [2.3-10.4]; P<0.001). Gross recruitment was 0.11 patients per site month versus 0.43 patients per site per month, respectively, before and after the amendment.
conclusionsIt is feasible to include IAT in a neuroprotectant trial for acute ischemic stroke. Criteria are presented for including such patients in a manner that is consistent with published evidence for IAT while still preserving the ability to test the role of the putative neuroprotectant. CLINICAL
trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02222714.
Indexed as
Clinical ProtocolsPatient SelectionBrain IschemiaClinical Trials as TopicDouble-Blind MethodHumansMechanical ThrombolysisNeuroprotective AgentsProtein CRecombinant ProteinsStrokeThrombolytic Therapy3K3A-APC proteinNeuroprotective AgentsProtein CRecombinant Proteinsactivated protein Cclinical trialneuroprotective agentsthrombectomythrombolysis
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NCT02222714ClinicalTrials.gov
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.