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Acute Ischemic StrokeNCT05897554

Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP)

A study testing intra-arterial alteplase in people with Acute Ischemic Stroke and Arterial Thrombosis, run by Xuanwu Hospital, Beijing 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

The CHOICE study suggested that the use of adjunct intra-arterial alteplase after successful endovascular reperfusion in large vessel occlusion acute ischemic strokes may result in a greater likelihood of excellent neurological outcome at 90 days. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
intra-arterial alteplase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
1 siteChina
Study dates
11 Aug 2023to 27 Mar 2025
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms and signs compatible with ischemia in the posterior circulation;
  • Basilar artery occlusion or vertebral artery occlusion without antegrade flow to the basilar artery confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA);
  • Age ≥18 years and ≤80 years;
  • Premorbid mRS ≤1;
  • National Institutes of Health Stroke Score (NIHSS) ≥6 at admission；
  • PC-ASPECTS on CT/CTA-Source Images/MRI-DWI 6-10；
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  • Treated with endovascular thrombectomy (EVT) resulting in an eTICI score ≥2b50 at end of the procedure；
  • Time from symptom onset to randomization<24 hours, including wake-up stroke and unwitnessed stroke; Time of onset of symptoms is defined as "last known well" (LKW) if symptoms are not witnessed or time of estimated basilar artery occlusion (defined as the time of sudden onset of basilar artery stroke symptoms, with no consideration of any preceding minor prodromal symptoms, as adjudicated by two neurologists) if symptoms are witnessed;
  • Informed consent obtained from the patient or his/her legal representative.

Who cannot join

  • Contraindication to Intravenous Thrombolysis (except time to treatment);
  • Complete clinical recovery in the angiography suite by end of MT procedure;
  • More than 3 passes of thrombectomy device;
  • Dissection of occluded artery or intraoperative bleeding on DSA after thrombectomy;
  • Patients in sedation and intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation;
  • Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
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  • Bilateral dilated pupils;
  • Severe contrast allergy or absolute contraindication to iodinated contrast;
  • Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs;
  • Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L);
  • Platelet <50*10^9/L, or aPTT >40 s, or PT >15 s;
  • Known genetic or acquired bleeding diathesis, deficiency of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours;
  • Known 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;
  • Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.);
  • Presumed vasculitis or septic embolization;
  • Suspicion of aortic dissection;
  • The patient has neurological disease or mental disorder before onset, which affects the assessment of the condition;
  • Females who are pregnant or in lactation;
  • Participating in other clinical trials that could confound the evaluation of the study;
  • Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital, Capital Medical University.

    Beijing, 100053

Other trials in China

About this study

Official title: Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion in the Posterior Circulation (IAT-TOP)

The CHOICE study suggested that the use of adjunct intra-arterial alteplase after successful endovascular reperfusion in large vessel occlusion acute ischemic strokes may result in a greater likelihood of excellent neurological outcome at 90 days. However, CHOICE was a phase-2 trial and almost exclusively enrolled anterior circulation occlusions. Therefore, data on the safety and efficacy of post-endovascular reperfusion IAT in posterior circulation stroke is lacking.

In general, anterior circulation strokes are associated with a higher risk of ICH than posterior circulation strokes. Therefore, we believe it might be safer to perform post-endovascular reperfusion IAT posterior circulation stroke. Also, there are more perforator artery in the posterior circulation, IAT would be more likely to show its benefit. Therefore, we would like to explore IA rt-PA for posterior circulation stroke after successful MT in our RCT.

In this study, one interim analysis will be performed when the enrollment volume reaches 50% of the total sample size (188 cases). DSMB will determine the premature termination or continuity of research.

Being tested
intra-arterial alteplase
Keywords
Intra-arterial thrombolysis, Alteplase, Large vessel occlusion, Mechanical thrombectomy, Endovascular treatment
Medical subject headings
Ischemic Stroke, Brain Infarction

What participants receive

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

  • intra-arterial alteplaseDrug

    Also called Intraarterial alteplase recombinant tissue plasminogen activator (r-tPA)

    For patients in the successful MT plus intra-arterial alteplase group, after successful recanalization, neurointerventionalists administered intra-arterial thrombolysis with alteplase according to protocol. The angiographic scores will be assessed immediately after intra-arterial thrombolysis.

Study groups in NCT05897554
Study groupRoleWhat they receive
Successful mechanical thrombectomy plus intra-arterial alteplase groupExperimentalFor patients in the successful MT plus intra-arterial alteplase group, after successful recanalization, neurointerventionalists administered intra-arterial thrombolysis with alteplase according to protocol. The angiographic scores will be assessed after intra-arterial thrombolysis.
Receives: Drug: intra-arterial alteplase
Successful mechanical thrombectomy only groupNo interventionFor patients in the successful MT only group, the choice of MT strategy will be made by the qualified neurointerventionalist, including stent retriever, aspiration and a combination technology. Patients who underwent more than 3 thrombectomy procedures were excluded from the study. Rescue therapy was performed at the discretion of the neurointerventionalist in case of the grade of stenosis at the occlusion site was presented to be more than 70% after MT.

What is being measured

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

  1. Rate of modified Rankin Scale (mRS) score of 0-2

    The mRS score range from 0 (no disability) to 6 (death)

    Measured: 90 days (±7 days) after randomization

Secondary outcomes (10)

  1. Change of eTICI

    Change of eTICI after intra-arterial thrombolysis

    Measured: Before intra-arterial thrombolysis vs. immediately after the completion of intra-arterial thrombolysis

  2. Rate of mRS score of 0-3

    The mRS score range from 0 (no disability) to 6 (death)

    Measured: 90 days (±7 days) after randomization

  3. Proportional distribution of modified Rankin Score

    The mRS score range from 0 (no disability) to 6 (death)

    Measured: 90 days (±7 days) after randomization

  4. Improvement of the National Institutes of Health Stroke Scale (NIHSS) score

    The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)

    Measured: 48 hours (±12 hours) after randomization

  5. Rate of early neurological improvement

    The NIHSS score 0-1 or decrease ≥8 from baseline NIHSS

    Measured: 48 hours (±12 hours) after randomization

  6. Improvement of the NIHSS score

    The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)

    Measured: 7 days (±1 days) after randomization or discharge

  7. EQ-5D-5L

    The EQ-5D 5-Levels (EQ-5D-5L) range from 5 (no problems) to 25 (extreme problems), which deceased patients have a utility of 0.

    Measured: 90 days (±7 days) after randomization

  8. Barthel Index

    The Barthel Index range from 0 (severe disability) to 100 (no disability)

    Measured: 90 days (±7 days) after randomization

  9. All-cause mortality

    Death defined as a mRS score of 6

    Measured: 90 days (±7 days) after randomization

  10. Rate of symptomatic intracranial hemorrhage (sICH)

    The sICH was assessed based on the Heidelberg Bleeding Classification, defined as 1) ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening; 2) ≥2 point in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; 3) Leading to intubation/hemicraniectomy/EVD placement or other major medical/surgical intervention; 4) Absence of alternative explanation for deterioration.

    Measured: Within 48 hours 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 posted9 Jun 2023
  2. Study start11 Aug 2023
  3. Primary completion27 Mar 2025
  4. Study completion27 Mar 2025

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897554
Sponsor's protocol ID
IAT-TOP
Status last verified
Aug 2025
First submitted
18 May 2023
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen W, Yang B, Bai X, Yi T, Wang H, Wen C, Liu Y, Ma L, Wu S, Liu S, Zhang L, Peng Y, Zhao Y, Song C, Cai X, Zhang G, Zheng W, Cheng T, Wei L, Xu L, Liu W, Han H, Cao H, Chang W, Fang P, Xu C, Ju D, Liu Y, Zhang J, Li J, Wang E, Zhang G, Yu J, Zeng G, Chen F, Li X, Dai Y, Guo X, Wu Y, Nguyen TN, Fischer U, Qureshi AI, Nogueira RG, Ji X, Jiao L; IAT-TOP Investigators. Intra-arterial Alteplase Thrombolysis After Successful Thrombectomy for AIS in the Posterior Circulation: The IAT-TOP Randomized Clinical Trial. JAMA Neurol. 2026 Jul 1;83(7):625-634. doi: 10.1001/jamaneurol.2026.1074.

    PubMed 42026933

  • Yang B, Bai X, Yi T, Wang H, Liu Y, Ma L, Liu S, Wu S, Zhang L, Peng Y, Nogueira RG, Chen W, Jiao L. Intra-arterial Alteplase Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP): Study protocol and rationale. Int J Stroke. 2025 Jul;20(6):750-755. doi: 10.1177/17474930251313940. Epub 2025 Jan 23.

    PubMed 39754489

Questions about this trial

What is this clinical trial studying?

A study testing intra-arterial alteplase in people with Acute Ischemic Stroke and Arterial Thrombosis, run by Xuanwu Hospital, Beijing 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 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 13 Aug 2025. 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.

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?

Rate of modified Rankin Scale (mRS) score of 0-2 (time frame: 90 days (±7 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 NCT05897554, which also lists 2 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 13 Aug 2025.

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