NCT03542188

Brief Summary

Should we prioritize thrombectomy or thrombolysis in acute stroke? Finding the answer to this question will improve treatment and outcome for stroke patients only by changing triage and transportation. And it will have implications for stroke patients around the world. The investigators propose a national investigator-driven, multi-center, randomised single-blinded clinical trial to investigate which treatment strategy is superior in patients with acute stroke and suspected large vessel occlusion (LVO): direct transport to a comprehensive stroke center for early endovascular therapy (EVT) or to a primary stroke center for early IV thrombolysis followed by secondary transport to a comprehensive stroke center for EVT if needed. Effective reperfusion therapy marks a new era within stroke medicine and has been driving major changes in the organization of care within the last decade. Timely thrombolysis and/or EVT in acute ischemic stroke is a key factor for improved outcome. Major stroke occur in 25% of all cases and is caused by LVO. Major strokes have approximately 60% risk of severe disability or death at three months if not treated. EVT is superior to thrombolysis in strokes caused by a LVO, but EVT is only performed in specialized centers due to the complexity of the treatment and need for skilled neurointerventionalists. A simple stroke severity score has been developed, that can identify most patients with LVO in the pre-hospital setting. This enables selection of patients with a suspected LVO to be transported without delay directly to a comprehensive stroke center for EVT while potentially bypassing a nearer primary stroke center for IV-thrombolysis. Study results will have major impact of future acute stroke treatment and organization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

4 years

First QC Date

May 16, 2018

Last Update Submit

December 13, 2022

Conditions

Stroke

Keywords

Large Vessel OcclusionStrokeEVT

Outcome Measures

Primary Outcomes (1)

  • mRS score after 90 days for AIS patients

    Blinded outcome of functional disability at 90 days using modified Rankin Score (mRS) ranging from no symptoms (score 0) to dead (score 6) analyzed as shift analysis in all patients ending with diagnosis of AIS.

    90 days

Secondary Outcomes (11)

  • mRS score after 90 days (shift analysis) for all randomized.

    90 days

  • mRS score after 90 days (shift analysis) for AIS patients without LVO

    90 days

  • mRS score after 90 days (shift analysis) for patients with hemorrhagic stroke

    90 days

  • mRS score after 90 days (shift analysis) for patients with stroke mimics

    90 days

  • mRS score ≤2 (independent) after 90 days for AIS patients treated with EVT

    90 days

  • +6 more secondary outcomes

Other Outcomes (5)

  • TimesEVT

    up to 24 hours

  • TimesIVT

    up to 24 hours

  • Successful reperfusion

    up to 24 hours

  • +2 more other outcomes

Study Arms (2)

Primary Stroke Center (PSC)

ACTIVE COMPARATOR

Transport to a primary stroke center for early IV-thrombolysis followed by a secondary transport to a comprehensive stroke center for EVT if needed.

Behavioral: Primary Stroke Center (PSC)Behavioral: Comprehensive Stroke Center (CSC)

Comprehensive Stroke Center (CSC)

EXPERIMENTAL

Direct transport to a comprehensive stroke center for IV-trombolysis and early EVT.

Behavioral: Comprehensive Stroke Center (CSC)

Interventions

Primary Stroke Center (PSC)BEHAVIORAL

Transport to a primary stroke center for early IV-thrombolysis followed by a secondary transport to a comprehensive stroke center for EVT if needed.

Primary Stroke Center (PSC)
Comprehensive Stroke Center (CSC)BEHAVIORAL

Direct transport to a comprehensive stroke center for IV-thrombolysis and early EVT.

Comprehensive Stroke Center (CSC)Primary Stroke Center (PSC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of acute stroke
  • No contraindication for IV thrombolysis
  • Stroke occurring ("pick up" place) in catchment area of a primary stroke center
  • The patient has Pre-hospital Acute Stroke Severity (PASS) score ≥2
  • Pre-stroke modified Rankin Score 0-2 (meaning living independently.)
  • Feasible to start IV-thrombolysis within 4.5 hours at CSC

You may not qualify if:

  • Syncope
  • Seizure
  • Known diagnosis of epilepsy
  • Medical condition and no signs of stroke (e.g. hypoglycemia)
  • In-hospital strokes
  • Life expectancy of less than 1 year.
  • Imaging showing ICH
  • Stroke mimics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (5)

  • Southerland AM, Johnston KC, Molina CA, Selim MH, Kamal N, Goyal M. Suspected Large Vessel Occlusion: Should Emergency Medical Services Transport to the Nearest Primary Stroke Center or Bypass to a Comprehensive Stroke Center With Endovascular Capabilities? Stroke. 2016 Jul;47(7):1965-7. doi: 10.1161/STROKEAHA.115.011149. Epub 2016 Feb 19. No abstract available.

    PMID: 26896433BACKGROUND

  • Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

    PMID: 26898852BACKGROUND

  • Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

    PMID: 25882510BACKGROUND

  • Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7.

    PMID: 27272487BACKGROUND

  • Behrndtz A, Blauenfeldt RA, Johnsen SP, Valentin JB, Gude MF, Al-Jazi MA, von Weitzel-Mudersbach P, Modrau B, Damgaard D, Hougaard KD, Hjort N, Diedrichsen T, Poulsen M, Schmitz ML, Fisher M, Andersen G, Simonsen CZ; TRIAGE-STROKE Trial Investigators. Transport Strategy in Patients With Suspected Acute Large Vessel Occlusion Stroke: TRIAGE-STROKE, a Randomized Clinical Trial. Stroke. 2023 Nov;54(11):2714-2723. doi: 10.1161/STROKEAHA.123.043875. Epub 2023 Oct 6.

    PMID: 37800374DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Claus Z Simonsen, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Grethe Andersen, Professor

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 31, 2018

Study Start

September 3, 2018

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)