Evidence map›Paper›PMID 33072884›Full record

ArticleEuropean stroke journal2020

Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease.

Joanna Wardlaw, Philip M W Bath, Fergus Doubal, Anna Heye, Nikola Sprigg, Lisa J Woodhouse, Gordon Blair, Jason Appleton, Vera Cvoro, Timothy England and 4 more

Open access · hybridAbstract read
In one paragraph

Article in European stroke journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. What have clinical trials taught us about brain health?Cerebral circulation - cognition and behavior · 2024
    Article
  7. Article
  8. Cerebral small vessel disease: Recent advances and future directions.International journal of stroke : official journal of the International Stroke Society · 2023
    Review
  9. Cellular Mechanisms of Electromagnetic Field in Traumatic Brain Injury.Journal of biotechnology and biomedicine · 2023
    Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. An introduction to therapeutic approaches to vascular cognitive impairment.Cerebral circulation - cognition and behavior · 2021
    Article
  16. Review
  17. Article
  18. Article
  19. Review
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 5 institutions in 1 country.

Joanna WardlawThe University of Edinburgh, Edinburgh, UK.ORCID https://orcid.org/0000-0002-9812-6642
Philip M W BathStroke Trials Unit, Division of Clinical Neuroscience, The University of Nottingham, Nottingham, UK.
Fergus DoubalThe University of Edinburgh, Edinburgh, UK.
Anna HeyeThe University of Edinburgh, Edinburgh, UK.
Nikola SpriggStroke Trials Unit, Division of Clinical Neuroscience, The University of Nottingham, Nottingham, UK.
Lisa J WoodhouseUniversity Hospital Coventry and Warwickshire, Coventry, UK.
Gordon BlairThe University of Edinburgh, Edinburgh, UK.
Jason AppletonUniversity of Nottingham, Derby, UK.
Vera CvoroThe University of Edinburgh, Edinburgh, UK.
Timothy EnglandLeeds General Infirmary, Leeds, UK.
Ahamad HassanUniversity College London Institute of Neurology, London, UK.
David John WerringUniversity College London Institute of Neurology, London, UK.
Alan MontgomeryStroke Trials Unit, Division of Clinical Neuroscience, The University of Nottingham, Nottingham, UK.
LACI-2 Trial Investigators
University of Edinburgh · GBUniversity of Nottingham · GBUniversity College London · GBLeeds General Infirmary · GBUniversity Hospital Coventry · GB

Funding

British Heart Foundation CS/15/5/31475Chief Scientist Office CAF/18/08
6 · The paper itself

Abstract

backgroundSmall vessel disease causes a quarter of ischaemic strokes (lacunar subtype), up to 45% of dementia either as vascular or mixed types, cognitive impairment and physical frailty. However, there is no specific treatment to prevent progression of small vessel disease.

aimWe designed the LACunar Intervention Trial-2 (LACI-2) to test feasibility of a large trial testing cilostazol and/or isosorbide mononitrate (ISMN) by demonstrating adequate participant recruitment and retention in follow-up, drug tolerability, safety and confirm outcome event rates required to power a phase 3 trial. METHODS AND

designLACI-2 is an investigator-initiated, prospective randomised open label blinded endpoint (PROBE) trial aiming to recruit 400 patients with prior lacunar syndrome due to a small subcortical infarct. We randomise participants to cilostazol v no cilostazol and ISMN or no ISMN, minimising on key prognostic factors. All patients receive guideline-based best medical therapy. Patients commence trial drug at low dose, increment to full dose over 2-4 weeks, continuing on full dose for a year. We follow-up participants to one year for symptoms, tablet compliance, safety, recurrent vascular events, cognition and functional outcomes, Trails B and brain MRI. LACI-2 is registered ISRCTN 14911850, EudraCT 2016-002277-35. SUMMARY: LACI-2 will determine feasibility, tolerability and provide outcome rates to power a large phase 3 trial to prevent progression of cerebral small vessel disease.

Indexed as

cilostazolisosorbide mononitrateLacunar strokerandomised clinical trialsmall vessel disease

Identifiers

PMID33072884
PMCPMC7538764
OpenAlexW3018172497

What OpenQuestion holds

Textmetadata
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.