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Stroke, Acute IschemicPhase 3PEARLNCT05856851

Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy

A Phase 3 study testing Alteplase in people with Stroke, Acute Ischemic, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites 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

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial aiming at evaluating the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical… 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?
Alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
2 sitesChina
Study dates
1 Aug 2023to 1 Nov 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

  • Aged 18 years or older.
  • Clinical diagnosis of acute ischemic stroke.
  • Time from symptom onset to randomization within 24 hours, including wake-up stroke or no-witness stroke; the onset time refers to "Last Known Well" (LKW).
  • CTA or MRA confirmed occlusion of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery; stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis. Patients with an eTICI score of 2b50-3 on the diagnostic cerebral angiography before mechanical thrombectomy are also eligible for the study.
  • Baseline NIHSS of 6-25.
  • NCCT/DWI-MRI ASPECTS ≥ 6;
  • Pre-stroke mRS score ≤ 1, or mRS >1 but not related to neurological disease (e.g., amputation, blindness).
  • Signed informed consent.

Who cannot join

  • Contraindication to rt-PA (except time to therapy).
  • Planned use of dual antiplatelet therapy within the first 24 hours after mechanical thrombectomy.
  • Angiographic evaluation showing dissection, severe stenosis, or complete occlusion of the carotid artery, which requires the use of carotid artery stents during the endovascular procedure.
  • Suspected cerebral vasculitis based on medical history and/or angiographic evaluation.
  • Women who are pregnant or breastfeeding.
  • Participation in other clinical trials.
Show all 19Show fewer
  • Preoperative intracranial hemorrhage confirmed by cranial CT or MRI.
  • Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.
  • Coagulation disorder with INR > 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset).
  • Platelet count <50X10^9/L.
  • Suspected vascular occlusion as a result of infective endocarditis.
  • Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl).
  • Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
  • Suspected aortic dissection.
  • Previous parenchymal organ surgery or biopsy in the last 1 month;
  • Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month;
  • SBP > 185 mmHg or DBP > 110 mmHg refractory to treatment.
  • Anticipated life expectancy < 6 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
  • Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong

Other trials in China

About this study

Official title: Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial aiming at evaluating the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy in improving the 90-day functional outcome.

Read the detailed description

This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy (eTICI 2b50/3). The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1.

Study intervention: (1) Participants in the experimental group will receive intra-arterial alteplase (a dose of 0.225 mg/kg and a maximum dose of 20 mg) after the mechanical thrombectomy, and will receive standard medical treatment after the procedure. (2) Participants in the control group will receive standard medical treatment without intra-arterial alteplase.

A total of 324 participants are anticipated to be recruited for this study, with 162 participants in each group (1:1 ratio).

Being tested
Alteplase
Medical subject headings
Ischemic Stroke

What participants receive

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

  • AlteplaseDrug

    Also called Intra-arterial alteplase after mechanical thrombectomy

    See arm/group descriptions.

Study groups in NCT05856851
Study groupRoleWhat they receive
Intra-arterial alteplaseExperimentalParticipants in the experimental group will receive a 15-minute continuous infusion of intra-arterial alteplase at a drug concentration of 1.0 mg/ml. 15 minutes after the start of intra-arterial thrombolysis, the infusion will be stopped and an angiogram will be performed to assess the eTICI score. If the angiographic eTICI score improves from the baseline score, the procedure will be terminated, otherwise, a new angiogram will be repeated 5-10 minutes after the end of drug administration.
Receives: Drug: Alteplase
Standard medical treatmentNo interventionParticipants allocated to the control group will receive standard medical treatment without intra-arterial alteplase after mechanical thrombectomy.

What is being measured

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

  1. The modified Rankin Scale score (mRS) 0-1

    The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.

    Measured: 90(±7) days

Secondary outcomes (7)

  1. Change of infarct volume from baseline

    The change of infarct volume at 7(±1) days or discharge (whichever occurred first) on non-contrast CT, or at 48(±12) hours on MRI

    Measured: 7(±1) days

  2. The volume of Tmax>6s on CTP

    The volume of Tmax>6s on CTP at 24(±12) hours

    Measured: 24(±12) hours

  3. The shift analysis of the modified Rankin Scale (mRS)

    The shift analysis of the modified Rankin Scale (mRS) at 90 days

    Measured: 90(±7) days

  4. The modified Rankin Scale score (mRS) 0-2

    The proportion of the modified Rankin Scale score (mRS) 0-2 at 90 days.

    Measured: 90(±7) days

  5. The modified Rankin Scale score (mRS) 0-3

    The proportion of the modified Rankin Scale score (mRS) 0-3 at 90 days.

    Measured: 90(±7) days

  6. The proportion of NIHSS 0-1 or ≥10 points reduction

    The proportion of NIHSS 0-1 or ≥10 points reduction at 48 (±12) hours

    Measured: 48 (±12) hours

  7. Quality of Life (EQ-5D-5L)

    The value of Quality of Life (EQ-5D-5L) at 90 days

    Measured: 90(±7) days

Timeline

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

  1. First posted12 May 2023
  2. Study start1 Aug 2023
  3. Primary completion15 Jan 2025
  4. Study completion1 Nov 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856851
Sponsor's protocol ID
SYSKY-2023-390-02
Acronym
PEARL
Status last verified
Aug 2024
First submitted
4 May 2023
Last updated
12 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Yajie Liu) upon reasonable request 6 months after the trial completion.

Publications

  • Xie D, Li H, Li D, Huang W, Lin X, Deng Z, Chen X, Yang X, Xu Y, Xiao S, Feng J, Tang Y, Rong X. Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial. J Am Heart Assoc. 2026 Oct 23:e049961. doi: 10.1161/JAHA.126.049961. Online ahead of print.

    PubMed 42924842

  • Bao M, Chen C, Sun H, Deng Z, Chen Y, Xue R, He B, Yang X, Li Y, Xiao S, Tang Y, Xu Y. Adjunctive intra-arterial alteplase after near-complete or complete reperfusion in acute ischemic stroke: A post hoc analysis of the PEARL Trial. Int J Stroke. 2026 Jun 9:17474930261461367. doi: 10.1177/17474930261461367. Online ahead of print.

    PubMed 42265863

  • Writing Committee for the PEARL Investigators; Yang X, He X, Xu Y, Pan D, Li K, Chen Y, Zhu Y, Pan Y, Yi T, Zhang M, Peng H, Huang W, Li D, Feng J, Chen J, Lu W, Liao B, Xie Y, Liao B, Yang L, Tang L, Han B, Liu Y, Lin P, Chen J, Liang Y, Li D, Weng G, Huang H, Li H, Li C, Peng Z, Li H, He B, Xue R, Bao M, Sun H, Hou H, Zhou H, Xiao Y, Li J, Zhang W, Chen X, Yan W, Pi Y, Deng Z, Wang J, Xie D, Liu M, Li H, Peng Q, Fang W, Lin X, Chen Z, Li H, Lin Y, Lin Q, Xiao S, Miao Z, Wang D, Nguyen TN, Nogueira RG, Liu Y, Tang Y; PEARL investigators. Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Acute Stroke: The PEARL Randomized Clinical Trial. JAMA. 2025 Oct 13;334(19):1728-39. doi: 10.1001/jama.2025.16876. Online ahead of print.

    PubMed 42262770

  • Yang X, He X, Pan D, Xu Y, Peng H, Li K, Zhang M, Zhu Y, Chen Y, He B, Zhou H, Li J, Hou H, Sun H, Liu Y, Tang Y. Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomised controlled trial. BMJ Open. 2024 Nov 5;14(11):e091059. doi: 10.1136/bmjopen-2024-091059.

    PubMed 39500603

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alteplase in people with Stroke, Acute Ischemic, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites 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 8 inclusion and 19 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

The modified Rankin Scale score (mRS) 0-1 (time frame: 90(±7) days). 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 NCT05856851, which also lists 4 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 12 Aug 2026.

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