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Stroke, Acute IschemicPhase 3NCT05634382

Endovascular Thrombectomy With and Without Intravenous Thrombolysis in Extended Time Window

A Phase 3 study testing Intravenous thrombolysis agents and endovascular thrombectomy in people with Stroke, Acute Ischemic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary hypothesis being tested in this trial is that ischemic stroke patients in large vessel occlusion of anterior circulation at 4.5 - 9 hours post onset of stroke will have improved clinical outcomes when given endovascular thrombectomy with intravenous thrombolysis compared with that of given direct… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute Ischemic
What is being tested?
Intravenous thrombolysis agents and endovascular thrombectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
1 siteChina
Study dates
3 Dec 2022to 28 Feb 2025
Phase
Phase 3
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

  • Patient/Legally Authorized Representative has signed the Informed Consent form
  • Age ≥ 18
  • Clinical signs consistent with an acute ischemic stroke
  • Neurological deficit with a NIHSS of ≥ 6 (deficits judged to be clearly disabling at presentation)
  • Patient is eligible for intravenous thrombolysis
  • Patient is eligible for endovascular treatment
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  • Randomization no later than 8 hours 45 minutes after stroke symptom onset and initiation of IV t-PA must be started within 9 hours of stroke symptoms onset (for stroke with unknown time of onset, the midpoint of the time last known to be well and symptom recognition time)
  • ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA (including the reconstructed CTA derived from CTP). And target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume is >/= 15 ml)
  • Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)

Who cannot join

  • Acute intracranial hemorrhage
  • Any contraindication for IV t-PA
  • Pre-treatment with IV t-PA
  • Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
  • Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys
  • Known current participation in a clinical trial (investigational drug or medical device)
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  • Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min or requirement for hemodialysis or peritoneal dialysis
  • Severe comorbid condition with life expectancy less than 90 days at baseline
  • Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)
  • Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
  • Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
  • Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
  • Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT
  • Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
  • Radiological confirmed evidence of cerebral vasculitis
  • CTA or MRA evidence of carotid artery dissection
  • Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA

Trial locations and contacts

1 site in 1 country.

Yi Chen, Doctor contact

08657113588187112

ileen@163.com

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

    Yi Chen, Doctor, ileen@163.com

    Recruiting

Other trials in China

About this study

Official title: Endovascular Thrombectomy With and Without Intravenous Thrombolysis for Large Vessel Anterior Circulation Stroke in Extended Time Window

The primary hypothesis being tested in this trial is that ischemic stroke patients in large vessel occlusion of anterior circulation at 4.5 - 9 hours post onset of stroke will have improved clinical outcomes when given endovascular thrombectomy with intravenous thrombolysis compared with that of given direct endovascular thrombectomy alone.

Read the detailed description

A number of multicenter randomized controlled trials have provided evidence supporting the application of endovascular therapy for acute ischemic stroke with anterior circulation large vessel occlusion. However, whether intravenous thrombolysis is necessary before endovascular therapy is still controversial. The combined trial data (including DEVT, DIRECT-MT, MR-CLEAN NO-IV and SKIP) assessing direct mechanical thrombectomy versus bridging therapy showed no difference in improving good functional outcome. However, a recent observational cohort study of 15832 patients treated with EVT, intravenous alteplase treatment was associated with better in-hospital survival and functional outcomes after adjusting for other covariates.

The 2019 AHA/ASA guidelines for the early management of patients with ischemic stroke states that mechanical thrombectomy is recommended for patients with anterior circulation large vessel occlusion within 6-24 hours of last known normal who meet the DWAN or DEFUSE-3 criteria (level I recommendation, level A evidence). The DEFUSE 3 perfusion-infarction core mismatch criteria is: core infarct volume <70mL, ischemic penumbra volume >15mL, and hypoperfusion volume/core infarct volume >1.8. Intravenous thrombolytic therapy is recommended for patients with ischemic stroke within 4.5 hours of onset. A meta-analysis of three randomized controlled trials recently published in the Lancet found that ischemic stroke at 4.5 to 9 hours of onset or wake stroke was consistent with a core infarct volume <70mL, a penumbra volume >10mL, and a hypoperfusion volume/core infarct volume >1.2. Benefit from intravenous thrombolytic therapy (3 month mRS 0-1 ratio, thrombolytic vs non-thrombolytic: 36% vs 29%). It was also strongly recommended by 2021 ESO guidelines on intravenous thrombolysis for acute ischemic stroke.

For these reasons the investigators hypothesize that endovacular thrombectomy bridging with intravenous thrombolysis is superior to direct thrombectomy in patients of stroke at 4.5 to 9 hours, guided with perfusion imaging.

Being tested
Intravenous thrombolysis agents, endovascular thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Intravenous thrombolysis agentsDrug

    Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA，alteplase) or TNK-tPA (Tenecteplase，Metalyse)

  • endovascular thrombectomyProcedure or surgery

    endovascular mechanical thrombectomy with nonspecific device

Study groups in NCT05634382
Study groupRoleWhat they receive
Intravenous thrombolysis bridging with endovascular thrombectomyExperimentalNot described
Receives: Drug: Intravenous thrombolysis agents; Procedure: endovascular thrombectomy
Direct endovascular thrombectomy without intravenous thrombolysisActive comparatorNot described
Receives: Procedure: endovascular thrombectomy

What is being measured

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

  1. Good clinical outcome

    Score in modified Rankin Scale (mRS) ≤ 2 (mRS is short for modified ranking score, with minimum value of 0 and maximum value of 6. Higher score means a worse outcome.)

    Measured: 90 days after randomization

Secondary outcomes (8)

  1. Mortality

    Mortality due to any cause

    Measured: 90 days after randomization

  2. Modified Rankin Scale (mRS) shift analysis

    (mRS is short for National Institute of health stroke scale, with minimum value of 0 and maximum value of 6. Higher score means a worse outcome.)

    Measured: day 0 and 90 days after randomization

  3. National Institute of Health Score Scale (NIHSS)

    (NIHSS is short for modified ranking score, with minimum value of 0 and maximum value of 42. Higher score means a worse outcome.)

    Measured: day 0 and day 1 after randomization

  4. Thrombolysis in Cerebral Infarction (TICI) scale

    TICI is for "Thrombolysis in cerebral Infarction", with minimum value of 0 and maximum value of 3. Higher score means a better reperfusion state.

    Measured: day 0 and day 1 after randomization

  5. Serious adverse events

    Leading to death or prolonged hospitalisation

    Measured: day 0 until 90 days after randomization

  6. Intracranial hemorrhage

    Hemorrhagic finding on CT or MRI

    Measured: day 1 after randomization

  7. Quality of life assessed by questionnaire

    Include but not limited to the Barthelindex of ADL, which is the abbreviation of " activities of daily living", with minimum value of 0 and maximum value of 100. Higher score means a worse outcome.

    Measured: 90 days after randomization

  8. Overall costs incurred during hospitalisation

    include charges and expenses of every description

    Measured: 90 days after randomization

Timeline

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

  1. First posted2 Dec 2022
  2. Study start3 Dec 2022
  3. Primary completion28 Nov 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634382
Sponsor's protocol ID
HOPE-BRIDGING
Status last verified
Feb 2023
First submitted
21 Nov 2022
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous thrombolysis agents and endovascular thrombectomy in people with Stroke, Acute Ischemic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Yi Chen, Doctor (08657113588187112, ileen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Good clinical outcome (time frame: 90 days after randomization). 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 NCT05634382.

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 14 Feb 2023.

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