Acute Ischemic StrokePhase 3SIMPLIFIEDNCT07606807
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window
A Phase 3 study testing Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study. It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging… 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?
- Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- Presumed acute ischemic stroke of the anterior circulation.
- Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'.
- Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
- Limited early ischemic changes on non-contrast CT (NCCT).
- Written informed consent signed by patients or their legally authorized representatives.
Who cannot join
- Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.
- Intracranial or subarachnoid hemorrhage identified on baseline NCCT.
- Endovascular thrombectomy (EVT) planned at the time of randomization.
- Pre-stroke mRS≥2.
- Allergy to the test drug and its ingredients.
- Severe head trauma or ischemic stroke in the last 3 months.
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- Intracranial or intraspinal surgery within 3 months before enrollment.
- Intracranial tumor or large-size aneurysm found before enrollment.
- Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
- Active visceral bleeding.
- Aortic arch dissection confirmed by examination or medical history.
- Infective endocarditis confirmed by examination or medical history.
- Platelet count less than 100 × 109 /L.
- Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
- Pregnant or lactating women.
- Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening.
- Uncontrolled hypertension with persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to medical management.
- Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness.
- Participating in other trials.
- Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xinguang Yang, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510120
Jinyuan Wang, 86-20-81332619, wangjy257@mail2.sysu.edu.cn
Xinguang Yang, MD, PhD, yangxinguang0926@163.com
About this study
Official title: rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study. It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).
Read the detailed description
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study with a target enrollment of at least 750 patients. The trial focuses on individuals with acute ischemic stroke (AIS) presenting within a 4.5 to 24-hour window who are not planned for endovascular thrombectomy (EVT). Patients meeting simplified imaging criteria based on non-contrast CT (NCCT) are randomized 1:1 to receive a single intravenous bolus of 0.25 mg/kg tenecteplase (TNK) or standard medical treatment. The primary outcome is the 90-day excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1. Safety outcomes include symptomatic intracranial hemorrhage (sICH) and 90-day mortality.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg), Standard medical treatment
- Keywords
- Intravenous Thrombolysis, Extended Time Window, Simplified Imaging, Non-contrast CT, 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.
Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)Drug
Patients randomized to the intervention arm will receive tenecteplase via a single intravenous bolus (0.25 mg/kg; maximum dose 25 mg), administered immediately following randomization.
Standard medical treatmentDrug
Patients in the control arm will receive standard medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intravenous tenecteplase Receives: Drug: Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) |
| Control Arm | Active comparator | Standard medical treatment Receives: Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent functional outcome
The proportion of mRS score 0-1 at 90 (±14) days.
Measured: at 90 (±14) days
Secondary outcomes (9)
Ordinal distribution of mRS
The proportion of mRS distribution at 90 (±14) days
Measured: at 90 (±14) days
Favorable functional outcome
The proportion of mRS score 0-2 at 90 (±14) days
Measured: at 90 (±14) days
Change in NIHSS Score at 24 (±12) hours
NIHSS score change from baseline at 24 (±12) hours
Measured: at 24 (±12) hours
Change in NIHSS Score at 7 (±1) days or discharge
NIHSS score change from baseline at 7 (±1) days or discharge
Measured: at 7 (±1) days or discharge
Quality of life (EQ-5D-5L)
Quality of life measured by EQ-5D-5L at 90 (±14) days
Measured: at 90 (±14) days
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage (sICH) within 36 hours from randomization (SITS-MOST criteria)
Measured: within 36 hours
Any intracranial hemorrhage
Any intracranial hemorrhage within 36 hours
Measured: within 36 hours
Major extracranial bleeding
Major extracranial bleeding within 36 hours (GUSTO criteria: moderate and severe bleeding)
Measured: within 36 hours
Mortality
All-cause mortality within 90 days
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, MD, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606807
- Sponsor's protocol ID
- SYSKY-2026-479-02
- Acronym
- SIMPLIFIED
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial
- ClinicalTrials.gov ID
- NCT07606807
- Acronym / sponsor ID
- SIMPLIFIED / SYSKY-2026-479-02
- Conditions
- Acute Ischemic Stroke
- Keywords
- Intravenous Thrombolysis, Extended Time Window, Simplified Imaging, Non-contrast CT, Tenecteplase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study. It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).
Detailed description
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study with a target enrollment of at least 750 patients. The trial focuses on individuals with acute ischemic stroke (AIS) presenting within a 4.5 to 24-hour window who are not planned for endovascular thrombectomy (EVT). Patients meeting simplified imaging criteria based on non-contrast CT (NCCT) are randomized 1:1 to receive a single intravenous bolus of 0.25 mg/kg tenecteplase (TNK) or standard medical treatment. The primary outcome is the 90-day excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1. Safety outcomes include symptomatic intracranial hemorrhage (sICH) and 90-day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)Intravenous tenecteplase |
| Control Arm | Active comparator | Drug: Standard medical treatmentStandard medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Presumed acute ischemic stroke of the anterior circulation.
- Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'.
- Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
- Limited early ischemic changes on non-contrast CT (NCCT).
Key exclusion criteria (20 listed)
- Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.
- Intracranial or subarachnoid hemorrhage identified on baseline NCCT.
- Endovascular thrombectomy (EVT) planned at the time of randomization.
- Pre-stroke mRS≥2.
- Allergy to the test drug and its ingredients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg)Patients randomized to the intervention arm will receive tenecteplase via a single intravenous bolus (0.25 mg/kg; maximum dose 25 mg), administered immediately following randomization. | Drug | Intervention Arm |
| Standard medical treatmentPatients in the control arm will receive standard medical treatment. | Drug | Control Arm |
Primary outcome
Excellent functional outcome
Time frame: at 90 (±14) days
The proportion of mRS score 0-1 at 90 (±14) days.
9 secondary outcomes
Ordinal distribution of mRS
Time frame: at 90 (±14) days
Favorable functional outcome
Time frame: at 90 (±14) days
Change in NIHSS Score at 24 (±12) hours
Time frame: at 24 (±12) hours
Change in NIHSS Score at 7 (±1) days or discharge
Time frame: at 7 (±1) days or discharge
Quality of life (EQ-5D-5L)
Time frame: at 90 (±14) days
Symptomatic intracranial hemorrhage
Time frame: within 36 hours
Any intracranial hemorrhage
Time frame: within 36 hours
Major extracranial bleeding
Time frame: within 36 hours
Mortality
Time frame: within 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinguang Yang, MD, PhD contact
Yamei Tang, MD, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenecteplase (rhTNK-tPA) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 6 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinyuan Wang (86-18558992193, wangjy257@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent functional outcome (time frame: at 90 (±14) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.