Evidence map›Paper›PMID 38676572›Full record

ArticleInternational journal of stroke : official journal of the International Stroke Society2024

A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke with Proven Occlusion (TEMPO-2): Rational and design of a multicenter, randomized open-label clinical trial.

Nishita Singh, Carol C Kenney, Ken S Butcher, Brian Buck, Philip A Barber, Thalia S Field, Philip M Choi, Amy Yx Yu, Timothy Kleinig, Ramana Appireddy and 4 more

Open access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of stroke : official journal of the International Stroke Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
9.3field-weighted citation impact, top 2% 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

6 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Hyperacute ischemic stroke care-Current treatment and future directions.International journal of stroke : official journal of the International Stroke Society · 2024
    Review
  4. Real-world comparative safety and efficacy of tenecteplaseTherapeutic advances in neurological disorders · 2021
    Article
  5. Review
  6. 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

14 authors at 11 institutions in 4 countries.

Nishita SinghNeurology Division, Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.ORCID 0000-0003-3647-0904
Carol C KenneyDepartments of Neurosciences, Radiology and Community Health Sciences, University of Calgary, Calgary, AB, Canada.
Ken S ButcherSchool of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia.
Brian BuckDivision of Neurology, Department of Medicine, University of Alberta, Edmonton, AB, Canada.
Philip A BarberDepartments of Neurosciences, Radiology and Community Health Sciences, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-6051-1078
Thalia S FieldVancouver Stroke Program, Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada.ORCID 0000-0002-1176-0633
Philip M ChoiDepartment of Neurosciences, Box Hill Hospital, Faculty of Medicine, Nursing and Health Sciences, Monash University, Box Hill, VIC, Australia.
Amy Yx YuDivision of Neurology, Department of Medicine, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, Canada.ORCID 0000-0002-7276-9551
Timothy KleinigDepartment of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.ORCID 0000-0003-4430-3276
Ramana AppireddyDivision of Neurology, Department of Medicine, Queen's University, Kingston, ON, Canada.
Carlos A MolinaVall d'Hebron Stroke Center, Barcelona, Spain.
Keith W MuirSchool of Psychology & Neuroscience, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.ORCID 0000-0001-9535-022X
Michael D HillDepartments of Neurosciences, Radiology and Community Health Sciences, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-6269-1543
Shelagh B CouttsDepartments of Neurosciences, Radiology and Community Health Sciences, University of Calgary, Calgary, AB, Canada.ORCID 0000-0001-5090-5105
University of Calgary · CABox Hill Hospital · AUQueen Elizabeth University Hospital · GBQueen's University · CARoyal Adelaide Hospital · AUSunnybrook Health Science Centre · CAUniversity of Alberta · CAUniversity of British Columbia · CAUniversity of Manitoba · CAUNSW Sydney · AUVall d'Hebron Institut de Recerca · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlmost half of acute ischemic stroke patients present with mild symptoms and there are large practice variations in their treatment globally. Individuals with an intracranial occlusion who present with minor stroke are at an increased risk of early neurological deterioration and poor outcomes. Individual patient data meta-analysis in the subgroup of patients with minor deficits showed benefit of alteplase in improving outcomes; however, this benefit has not been seen with intravenous alteplase in published randomized trials.

designTEMPO-2 (A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion) is a prospective, open label with blinded outcome assessment, randomized controlled trial, designed to test the superiority of intravenous tenecteplase (0.25 mg/kg) over nonthrombolytic standard of care, with an estimated sample size of 1274 patients. Adult patients presenting with acute ischemic stroke with the National Institutes of Health Stroke Scale (NIHSS) ⩽ 5 and visible arterial occlusion or perfusion deficit within 12 h of onset are randomized to receive either tenecteplase (0.25 mg/kg) or standard of care. The primary outcome is return to baseline neurological functioning, measured by the modified Rankin scale (mRS) at 90 days. Safety outcomes include death and symptomatic hemorrhage (intra or extra-cranial). Other secondary outcomes include mRS 0-1, mRS 0-2, ordinal shift analysis of the mRS, partial, and full recanalization on follow-up computed tomography angiogram.

conclusionResults of this trial will aid in determining whether there is benefit of using tenecteplase (0.25 mg/kg) in treating patients presenting with minor stroke who are at high risk of developing poor outcomes due to presence of an intracranial occlusion. DATA ACCESS STATEMENT: Data will be available upon reasonable request.

Indexed as

Fibrinolytic AgentsIschemic StrokeTenecteplaseAgedEquivalence Trials as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicStandard of CareTissue Plasminogen ActivatorTreatment OutcomeFibrinolytic AgentsTenecteplaseTissue Plasminogen ActivatorAcute stroke therapyclinical trialminor strokeprotocolsTenecteplasethrombolysis

Identifiers

PMID38676572
PMCPMC11298112
OpenAlexW4395690671

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.