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Acute Ischemic StrokePhase 4OPTIONNCT05752916

Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window

A Phase 4 study testing rhTNK-tPA and Antiplatelet Agents in people with Acute Ischemic Stroke, 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

This study is designed to evaluate the efficacy of IV rhTNK-tPA between 4.5 to 24 hours from symptom onset in patients presenting with a non-large vessel occlusion ischemic stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
rhTNK-tPA and Antiplatelet Agents
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
1 siteChina
Study dates
2 Jun 2023to 28 Oct 2025
Phase
Phase 4
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

  • Clinical diagnosis of acute ischemic stroke
  • Age≥18 years
  • Pre-stroke mRS score≤1 points
  • Disabling stroke defined as follows:
  • Baseline NIHSS score 6-25 at the time of randomization,
  • Or NIHSS 4-5 with disabling deficit (e.g. hemianopia, aphasia, loss of hand function) as determined by the managing clinician
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  • Onset (last-seen-well) time to treatment time between 4.5 and 24 hours
  • Written informed consent from patients or legally responsible representatives
  • The presence of a Target Mismatch on CT perfusion: ischemic core volume<50ml (defined as rCBF<30%), mismatch ratio≥1.2 (Tmax>6 sec lesion/core volume lesion), mismatch volume≥10ml

Who cannot join

  • Treatment with a thrombolytic within the last 72 hours or intention to receive intravenous thrombolysis
  • Contraindication to thrombolysis
  • Planned or anticipated treatment with endovascular therapy
  • Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in a NIHSS score<4 at randomization
  • Pregnancy or lactating; formal testing needed in women of childbearing potential
  • Brain tumor (with mass effect)
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  • Hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  • Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, international normalized ratio (INR) >1.7 or prothrombin time >15s; if use of any direct oral anticoagulant within the last 48 hours; if use of heparin/heparinoid within the last 24 hours
  • Use of glycoprotein Ⅱb-Ⅲa inhibitors within the last 72 hours
  • Baseline platelet count <100,000/μL
  • Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate <30ml/min or serum creatinine >220mmol/L (2.5mg/dl)
  • Suspected aortic dissection
  • Major surgery or biopsy within the last 1 month
  • Any active bleeding within the previous 1 month (including gastrointestinal or urinary bleeding)
  • Known severe, life-threatening allergy (more severe than skin rash) to contrast agents
  • Severe, uncontrolled hypertension (systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg)
  • Any terminal illness such that the patient would not be expected to survive more than half a year
  • Current participation in any investigational study that may confound outcome assessment of the study
  • Any condition that, in the judgement of the investigator, is inappropriate for participation in the trial or could impose hazards to the patient (e.g. inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders)
  • Specific Neuroimaging Exclusion Criteria:
  • Evidence of acute intracranial hemorrhage
  • Acute large vessel occlusion on magnetic resonance/ computed tomography angiography, including internal carotid artery (ICA), middle cerebral artery M1 segment (MCA-M1）, vertebral artery and basilar artery

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital, Capital Medical University

    Beijing

Other trials in China

About this study

Official title: Intravenous Thrombolysis With Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Acute Non-large Vessel Occlusion in Extended Time Window--A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial

This study is designed to evaluate the efficacy of IV rhTNK-tPA between 4.5 to 24 hours from symptom onset in patients presenting with a non-large vessel occlusion ischemic stroke.

Read the detailed description

OPTION is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) controlled trial of thrombolysis with rhTNK-tPA versus standard of care. A total of 568 patients will be enrolled at approximately 40 centers around China.

Being tested
rhTNK-tPA, Antiplatelet Agents
Keywords
acute ischemic stroke, extended time window, non-large vessel occlusion, intravenous thrombolysis
Medical subject headings
Ischemic Stroke

What participants receive

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

  • rhTNK-tPADrug

    Recombinant human TNK tissue-type plasminogen activator. Patients will receive intravenous rhTNK-tPA (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds).

  • Antiplatelet AgentsDrug

    Also called Aspirin, Clopidogrel

    Aspirin (150-300mg) is offered to patients allocated in the control arm, unless contraindicated. According to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023, 150-300mg aspirin alone is recommended for acute stroke treatment in patients who are otherwise eligible for intravenous thrombolysis or EVT as soon as possible (Class 1 of recommendation, Level A of evidence). The aspirin dose can be changed to 50-300 mg/day after the acute phase. Clopidogrel is indicated as an alternative in case of aspirin intolerance (Class 2 of recommendation, Level C of evidence)

Study groups in NCT05752916
Study groupRoleWhat they receive
Intravenous rhTNK-tPAExperimentalrhTNK-tPA(0.25mg/kg) given as a single, intravenous bolus immediately upon randomization. Experimental treatment will be administered as a single intravenous bolus over 5-10 seconds as per the standard manufacturers' instructions for use.
Receives: Drug: rhTNK-tPA
Standard Medical TreatmentActive comparatorAntiplatelet therapy (aspirin or clopidogrel alone) at the discretion of local investigators according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
Receives: Drug: Antiplatelet Agents

What is being measured

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

  1. Excellent functional outcome

    Proportion of subjects with mRS 0-1 at 90±7 days

    Measured: 90±7 days

Secondary outcomes (7)

  1. modified Rankin Scale (mRS) score

    Ordinal distribution of mRS at 90±7 days; 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±7 days

  2. Good functional outcome

    Proportion of subjects with mRS 0-2 at 90±7 days

    Measured: 90±7 days

  3. Rate of successful reperfusion

    >90% reduction of the Tmax>6s lesion volumes between the baseline and early follow-up at 24 hours (-2/+12 hours)

    Measured: 24 hours (-2/+12 hours)

  4. Infarct volume at 24 hours (-2/+12 hours)

    The infarct volume is determined on evaluated on NCCT at 24 hours (-2/+12 hours)

    Measured: 24 hours (-2/+12 hours)

  5. Early clinical recovery

    Proportion of subjects with NIHSS score≥8 improved compared with baseline or with NIHSS 0-1 at 24 hours (-2/+12 hours)

    Measured: 24 hours (-2/+12 hours)

  6. Change of National Institutes of Health Stroke Scale (NIHSS)

    Change of NIHSS score from baseline to 7 days (±2days)

    Measured: 7±2 days

  7. Functional health status and quality of life

    Functional health status and quality of life (EQ-5D-5L) at 90±7 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 posted3 Mar 2023
  2. Study start2 Jun 2023
  3. Primary completion28 Oct 2025
  4. Study completion28 Oct 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized, open label, blinded-endpoint (PROBE)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752916
Sponsor's protocol ID
[2022]205
Acronym
OPTION
Status last verified
Apr 2025
First submitted
9 Feb 2023
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ma G, Mo R, Zuo Y, Ma Q, Zhao G, Yao X, Liang J, Zhou L, He Y, Long F, Yuan Z, Liu L, Han G, Tan Y, Ai Z, Cai C, Liu J, Zhang L, Yang H, Yi T, Li L, Fu Y, Zhang Y, Shao X, Yu Z, Wu S, Du Y, Mao L, Guo H, Chen X, Chen Y, Zhao Q, Chi L, Liu Y, Zhang H, Li G, Meng S, Wu Y, Wu J, Jiang Z, Lei S, Gao D, Zhong L, Fiehler J, Wang D, Nguyen TN, Saver JL, Hao J; OPTION Investigators. Tenecteplase for Acute Non-Large Vessel Occlusion 4.5 to 24 Hours After Ischemic Stroke: The OPTION Randomized Clinical Trial. JAMA. 2026 Apr 7;335(13):1137-1147. doi: 10.1001/jama.2026.0210.

    PubMed 41642827

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rhTNK-tPA and Antiplatelet Agents in people with Acute Ischemic Stroke, 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 22 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 2 Dec 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Excellent functional outcome (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 NCT05752916, which also lists 1 linked publication.

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 2 Dec 2025.

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