Evidence map›Paper›PMID 39509663›Full record

Trial reportNeurology2024

Consent-Related Outcomes in the Alteplase Compared to Tenecteplase Trial.

Michel C Shamy, Brian Dewar, Yan Deschaintre, Nishita Singh, Carol Kenney, Mohammed A Almekhlafi, Ayoola Ademola, Brian H Buck, Tolulope T Sajobi, Luciana Catanese and 6 more

Abstract readMulticenter StudyRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Neurology, 2024. 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
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. 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.

Michel C ShamyFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0002-0085-6816
Brian DewarFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0002-9222-5420
Yan DeschaintreFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.
Nishita SinghFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0003-3647-0904
Carol KenneyFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.
Mohammed A AlmekhlafiFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0001-9550-8197
Ayoola AdemolaFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.
Brian H BuckFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0002-7984-6062
Tolulope T SajobiFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0002-5696-5552
Luciana CataneseFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0002-8696-5211
Kayla D SageFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0001-6571-5531
Dar DowlatshahiFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0003-1379-3612
Laura C GioiaFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.
Aleksander TkachFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0009-0009-4063-4431
Richard H SwartzFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.
Bijoy K MenonFrom the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.ORCID 0000-0002-3466-496X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesIn recent years, researchers have sought to address the challenges of obtaining informed consent for participation in acute stroke trials. We studied outcomes related to the use of deferral of consent in the phase 3 Alteplase Compared to Tenecteplase (AcT) trial.

methodsAs part of our protocol, we captured methods of consent, participant withdrawals, door-to-randomization times, and door-to-needle times. Participants at 3 sites were invited to complete a survey of attitudes regarding consent for AcT and for acute stroke trials generally.

resultsThe AcT trial enrolled 1,600 participants from 22 centers across Canada of whom 1,537 were enrolled through deferral of consent (96.0%) and 63 (4.0%) were enrolled by prospective verbal consent followed by written informed consent. Of those enrolled by deferral of consent, 95% (1,454/1,537) consented to ongoing participation. Door-to-randomization times were similar regardless of method of consent, with an overall median of 30 minutes (interquartile range [IQR] 22-42): 29 minutes (IQR 22-42) in the deferral of consent group vs 32 minutes (IQR 25-44) in the prospective consent group ( DISCUSSION: Deferral of consent was broadly acceptable to participants in the AcT trial as demonstrated by low rates of withdrawal and by survey results. Door-to-randomization times using deferral of consent in AcT were short, although a system of prospective verbal consent used at 1 center took only slightly longer. These results support the importance of innovation around consent for acute stroke trials.

Indexed as

Fibrinolytic AgentsInformed ConsentStrokeTenecteplaseTissue Plasminogen ActivatorAgedCanadaFemaleHumansIschemic StrokeMaleMiddle AgedFibrinolytic AgentsTenecteplaseTissue Plasminogen Activator

Identifiers

PMID39509663
PMCPMC11558543

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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.