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Acute Ischemic StrokePhase 2/3NCT05684172

Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation

A Phase 2/3 study testing Tenecteplase and endovascular thrombectomy alone in people with Acute Ischemic Stroke and Intracranial Artery Occlusion, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: Recently, one prospective multicenter RCT reported a potential beneficial effect of intra-arterial alteplase following successful endovascular thrombectomy (EVT) in patients with an acute intracranial large vessel occlusion. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tenecteplase and endovascular thrombectomy alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteChina
Study dates
24 Jan 2023to 24 Nov 2023
Phase
Phase 2/3
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

  • Acute ischemic stroke patients with symptomatic intracranial large vessel occlusion (LVO) in the intracranial vertebral artery, basilar artery, or the P1 segment of the posterior cerebral artery.
  • Treated with endovascular thrombectomy (EVT) resulting in an eTICI score 2b50/3 at end of the procedure.
  • Age of 18 years or older;
  • National Institutes of Health Stroke Scale (NIHSS) score on admission≥6;
  • Posterior Circulation ASPECTS ≥ 6 on CT/CTA-Source Images/MRI-DWI.
  • Time from estimated time of basilar artery occlusion to randomization<24 hours;
  • Written informed consent.

Who cannot join

  • Pre-existing dependency with mRS >1;
  • Contraindication to Intravenous Thrombolysis (except time to therapy);
  • Complete clinical recovery in the angiography suite by end of EVT procedure;
  • Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive;
  • Severe contrast allergy or absolute contraindication to iodinated contrast;
  • Participation in other investigational drug or device clinical trials;
Show all 20Show fewer
  • Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs;
  • Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours;
  • platelets <100 000/mm3, aPTT >40 s, or PT >15 s; Blood glucose < 2.7 or >22.2 mmol/L;
  • Severe renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30, or patient requires hemodialysis or peritoneal dialysis;
  • Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal;
  • Suspicion of aortic dissection;
  • Presumed vasculitis or septic embolization;
  • Life expectancy < 1 year;
  • Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.)；
  • CT/MR shows intracranial hemorrhage;
  • Ischemic stroke within 3 months;
  • Severe head trauma within 3 months;
  • Major surgery or severe trauma within the last 2 weeks.
  • History of prior intracranial hemorrhage.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine

    Hefei, Anhui, 239300

Other trials in China

About this study

Official title: Trial of Intra-arterial Tenecteplase Following Successful Endovascular Thrombectomy on Safety and Efficacy in Patients With Large Vessel Occlusion of Posterior Circulation - a Multicenter Randomized Clinical Trial (ATTENTION IA)

Rationale: Recently, one prospective multicenter RCT reported a potential beneficial effect of intra-arterial alteplase following successful endovascular thrombectomy (EVT) in patients with an acute intracranial large vessel occlusion. In 2018, another prospective multicenter RCT supported the superiority of tenecteplase over alteplase in ischemic stroke patients with large vessel occlusion.

Objective: To assess the effect of EVT in addition to intra-arterial tenecteplase compared to EVT alone, in patients with large vessel occlusion of posterior circulation, on functional and safety outcomes.

Read more

Study design: This is a parallel group, randomized clinical trial of EVT with IA-TNK versus EVT. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow-up.

Study population: Patients with acute intracranial large vessel occlusion of posterior circulation and an eTICI 2b-3 after EVT.

Main study parameters/outcomes: The primary effect parameter will be excellent functional status at day 90 defined as a modified Rankin Score (mRS) of 0-1. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

Being tested
Tenecteplase, endovascular thrombectomy alone
Keywords
thrombectomy, endovascular treatment, mechanical thrombectomy techniques, tenecteplase
Medical subject headings
Ischemic Stroke

What participants receive

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

  • TenecteplaseDrug

    If patients are randomized and assigned to receive intra-arterial tenecteplase thrombolysis, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the pontine arteries.

  • endovascular thrombectomy aloneOther

    Patients will receive randomization if the eTICI score on cerebral angiography is 2b-3 and will stop the procedure if they have been assigned to the control group.

Study groups in NCT05684172
Study groupRoleWhat they receive
endovascular thrombectomyActive comparatorFor patients randomized to the control group, EVT has to be completed within 24 hours of stroke onset. The choice of EVT strategy will be made by the treating neurointerventionalist. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.
Receives: Other: endovascular thrombectomy alone
endovascular thrombectomy+intra-arterial tenecteplaseExperimentalFor patients randomized to the endovascular treatment arm, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the lenticulostriates branches. The administration of TNK will be infused for 15 seconds.
Receives: Drug: Tenecteplase; Other: endovascular thrombectomy alone

What is being measured

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

  1. a modified Rankin Score of 0-1

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    Measured: 90 (± 14 days) after procedure

Secondary outcomes (5)

  1. a modified Rankin Score of 0-3

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    Measured: 90 (± 14 days) after procedure

  2. Modified Rankin Score

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    Measured: 90 (± 14 days) after procedure

  3. NIHSS score

    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.

    Measured: 24 hours after procedure

  4. mortality

    (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%

    Measured: 90 (± 14 days) after procedure

  5. symptomatic intracerebral hemorrhage (ICH)

    SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.

    Measured: within 72 hours after procedure

Timeline

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

  1. First posted13 Jan 2023
  2. Study start24 Jan 2023
  3. Primary completion24 Aug 2023
  4. Study completion24 Nov 2023

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684172
Sponsor's protocol ID
ATTENTION IA
Status last verified
Apr 2024
First submitted
5 Jan 2023
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hu W, Nguyen TN, Qureshi M, Chen Z, Tao C, Li R, Yi TY, Feng G, Su J, Cui T, Cao Z, Wang H, Zeng G, Yuan G, Jing X, Luo C, Zhu Y, Qureshi AI, Nogueira RG, Liu X, Abdalkader M. Noncontrast CT vs CT Perfusion Imaging in Patients With Basilar Artery Occlusion: Analysis of the ATTENTION and ATTENTION IA Trials. Neurology. 2025 Aug 12;105(3):e213911. doi: 10.1212/WNL.0000000000213911. Epub 2025 Jul 17.

    PubMed 40674670

  • Hu W, Tao C, Wang L, Chen Z, Li D, Chen W, Yi T, Xu L, Yu C, Wang T, Yao X, Cui T, Yuan G, Su J, Chen L, Zhou Z, Ma Z, Wang J, Wang B, Han H, Wang H, Chen J, Zhou P, Cao Z, Ren Y, Cai X, Shi H, Zhang G, Yu L, Yuan X, Li J, Zeng G, Ni C, Li T, Wu Y, Li Y, Li K, Liu Y, Wang Y, Jin Y, Liu H, Wen J, Sun J, Zhu Y, Li R, Zhang C, Liu T, Song J, Wang L, Cheng J, Qureshi AI, Nguyen TN, Saver JL, Nogueira RG, Liu X. Intra-arterial tenecteplase after successful endovascular recanalisation in patients with acute posterior circulation arterial occlusion (ATTENTION-IA): multicentre randomised controlled trial. BMJ. 2025 Jan 14;388:e080489. doi: 10.1136/bmj-2024-080489.

    PubMed 39809509

  • Tao C, Li R, Sun J, Zhu Y, Wang L, Zhang C, Liu T, Song J, Qureshi AI, Abdalkader M, Nguyen TN, Saver JL, Nogueira RG, Hu W. Intra-arterial tenecteplase following endovascular therapy in patients with acute posterior circulation arterial occlusion: study protocol and rationale. J Neurointerv Surg. 2024 Dec 26;17(e1):e68-e73. doi: 10.1136/jnis-2023-021076.

    PubMed 38124230

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tenecteplase and endovascular thrombectomy alone in people with Acute Ischemic Stroke and Intracranial Artery Occlusion, run by The First Affiliated Hospital of University of Science and Technology of China 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 7 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: finished, as of the sponsor's last update on 11 Apr 2024. 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 combined 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

a modified Rankin Score of 0-1 (time frame: 90 (± 14 days) after procedure). 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 NCT05684172, which also lists 3 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 11 Apr 2024.

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