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Ischemic StrokePhase 2EXTEND-IANCT01492725

Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial

A Phase 2 study testing Intra-arterial Clot Retrieval with Solitaire device and intravenous tissue plasminogen activator (tPA) in people with Ischemic Stroke, run by Neuroscience Trials Australia at 9 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Patients presenting to the emergency department with acute ischaemic stroke, who are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch to determine their eligibility for randomisation into the trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Intra-arterial Clot Retrieval with Solitaire device and intravenous tissue plasminogen activator (tPA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
9 sitesin 2 countries
Study dates
Jun 2012to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients presenting with anterior circulation acute ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset
  • Patient, family member or legally responsible person depending on local ethics requirements has given informed consent
  • Patient"s age is ≥18 years
  • Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset.
  • Imaging inclusion criteria
  • Dual target:
  • Arterial occlusion on CTA or MRA of the ICA, M1 or M2
  • Mismatch - Using CT or MRI with a Tmax >6 second delay perfusion volume and either CT-rCBF or DWI infarct core volume. a) Mismatch ratio of greater than 1.2, and b) Absolute mismatch volume of greater than 10 ml, and. c) Infarct core lesion volume of less than 70mL

Who cannot join

  • Intracranial haemorrhage (ICH) identified by CT or MRI
  • Rapidly improving symptoms at the discretion of the investigator
  • Pre-stroke mRS score of ≥ 2 (indicating previous disability)
  • Inability to access the cerebral vasculature in the opinion of the neurointerventional team
  • Contra indication to imaging with MR with contrast agents
  • Participation in any investigational study in the previous 30 days
Show all 20Show fewer
  • Any terminal illness such that patient would not be expected to survive more than 1 year
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
  • Pregnant women
  • Previous stroke within last three months
  • Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
  • Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6)
  • Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
  • Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Prior use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) is permitted.
  • Clinically significant hypoglycaemia.
  • Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator.
  • Hereditary or acquired haemorrhagic diathesis
  • Gastrointestinal or urinary bleeding within the preceding 21 days
  • Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
  • Exposure to a thrombolytic agent within the previous 72 hrs

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Western Hospital

    Melbourne, Victoria, 3011

  • Austin Hospital

    Melbourne, Victoria, 3084

  • Box Hill Hospital

    Melbourne, Victoria, 3128

  • Monash Medical Centre

    Melbourne, Victoria, 3168

  • Royal Melbourne Hospital

    Melbourne, Victoria

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2605

Other trials in Australia

New Zealand1 site

  • Auckland Hospital

    Grafton, Auckland, 1001

Other trials in New Zealand

About this study

Official title: A Randomized Controlled Trial of Intra-arterial Reperfusion Therapy After Standard Dose Intravenous t-PA Within 4.5 Hours of Stroke Onset Utilizing Dual Target Imaging Selection.

Patients presenting to the emergency department with acute ischaemic stroke, who are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch to determine their eligibility for randomisation into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

Conditions
Ischemic Stroke
Being tested
Intra-arterial Clot Retrieval with Solitaire device, intravenous tissue plasminogen activator (tPA)
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-arterial Clot Retrieval with Solitaire deviceDevice

    Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours.

  • intravenous tissue plasminogen activator (tPA)Genetic

    Standard care IV tPA therapy administered as per registered product information

Study groups in NCT01492725
Study groupRoleWhat they receive
Intra-arterial Clot Retrieval after iv tPAExperimentalNot described
Receives: Device: Intra-arterial Clot Retrieval with Solitaire device
Standard care iv tPAActive comparatorNot described
Receives: Genetic: intravenous tissue plasminogen activator (tPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reperfusion at 24 hours (CT or MR perfusion imaging)

    Measured: 24 hours post stroke onset

  2. Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS)

    NIHSS - reduction >/= 8 points or reaching 0-1)

    Measured: 3 days post stroke onset

Secondary outcomes (10)

  1. Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging)

    Measured: 24 hours post stroke onset

  2. Recanalisation at 24 hrs post stroke (CT or MR angiography)

    Measured: 24 hours post stroke onset

  3. Infarct growth within 24 hrs (CT and MRI)

    Measured: 24 hours post stroke onset

  4. Stroke severity (NIHSS) at 24 hours

    Measured: 24 hours post stroke onset

  5. Symptomatic intra-cranial hemorrhage (ECASS type 2 parenchymal hematoma on CT or MRI combined with >/=4 point deterioration in NIHSS within 36 hours of treatment).

    Measured: within 36 hours of intervention

  6. Death due to any cause

    Measured: 3 months

  7. Modified Rankin Scale (mRS) 0-1 at 3 months

    Measured: 3 months

  8. Categorical shift in mRS at 3 months

    Measured: 3 months

  9. NIHSS reduction 8 points or reaching 0-1 at 3 months

    Measured: 3 months

  10. Modified Rankin Scale (mRS) 0-2 at 3 months

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2011 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Why it stopped: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492725
Sponsor's protocol ID
NTA1101
Acronym
EXTEND-IA
Status last verified
Dec 2014
First submitted
20 Nov 2011
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Sarraj A, Albers GW, Mitchell PJ, Hassan AE, Abraham MG, Blackburn S, Sharma G, Yassi N, Kleinig TJ, Shah DG, Wu TY, Hussain MS, Tekle WG, Gutierrez SO, Aghaebrahim AN, Haussen DC, Toth G, Pujara D, Budzik RF, Hicks W, Vora N, Edgell RC, Slavin S, Lechtenberg CG, Maali L, Qureshi A, Rosterman L, Abdulrazzak MA, AlMaghrabi T, Shaker F, Mir O, Arora A, Martin-Schild S, Sitton CW, Churilov L, Gupta R, Lansberg MG, Nogueira RG, Grotta JC, Donnan GA, Davis SM, Campbell BCV; SELECT, EXTEND-IA, EXTEND-IA TNK, and EXTEND-IA TNK Part-II Investigators. Thrombectomy Outcomes With General vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From the EXTEND-IA Trials and SELECT Study. Neurology. 2023 Jan 17;100(3):e336-e347. doi: 10.1212/WNL.0000000000201384. Epub 2022 Oct 26.

    PubMed 36289001

  • Ng FC, Churilov L, Yassi N, Kleinig TJ, Thijs V, Wu T, Shah D, Dewey H, Sharma G, Desmond P, Yan B, Parsons M, Donnan G, Davis S, Mitchell P, Campbell B. Prevalence and Significance of Impaired Microvascular Tissue Reperfusion Despite Macrovascular Angiographic Reperfusion (No-Reflow). Neurology. 2022 Feb 22;98(8):e790-e801. doi: 10.1212/WNL.0000000000013210. Epub 2021 Dec 14.

    PubMed 34906976

  • Campbell BCV, Mitchell PJ, Churilov L, Keshtkaran M, Hong KS, Kleinig TJ, Dewey HM, Yassi N, Yan B, Dowling RJ, Parsons MW, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Rice H, de Villiers L, Ma H, Desmond PM, Meretoja A, Cadilhac DA, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular Thrombectomy for Ischemic Stroke Increases Disability-Free Survival, Quality of Life, and Life Expectancy and Reduces Cost. Front Neurol. 2017 Dec 14;8:657. doi: 10.3389/fneur.2017.00657. eCollection 2017.

    PubMed 29312109

  • Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.

    PubMed 25671797

  • Campbell BC, Mitchell PJ, Yan B, Parsons MW, Christensen S, Churilov L, Dowling RJ, Dewey H, Brooks M, Miteff F, Levi C, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Kleinig T, Scroop R, Chryssidis S, Barber A, Hope A, Moriarty M, McGuinness B, Wong AA, Coulthard A, Wijeratne T, Lee A, Jannes J, Leyden J, Phan TG, Chong W, Holt ME, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA investigators. A multicenter, randomized, controlled study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA). Int J Stroke. 2014 Jan;9(1):126-32. doi: 10.1111/ijs.12206. Epub 2013 Nov 10.

    PubMed 24207098

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intra-arterial Clot Retrieval with Solitaire device and intravenous tissue plasminogen activator (tPA) in people with Ischemic Stroke, run by Neuroscience Trials Australia at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reperfusion at 24 hours (CT or MR perfusion imaging) (time frame: 24 hours post stroke onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492725, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.

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