Acute Ischemic StrokePhase 3PEARL-DOACNCT07092709
Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users
A Phase 3 study testing Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) 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
An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind trial to determine the efficacy and safety of intravenous tenecteplase thrombolysis in acute ischemic stroke (AIS) patients with recent direct oral anticoagulants (DOACs) intake in improving the 90-day functional outcome. 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 (TNK) (0.25 mg/kg, to maximum of 25mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 912 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2025to 31 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.
- Clinically diagnosed with acute ischemic stroke.
- DOACs intake within 48 hours prior to enrollment, or on an ongoing DOACs therapy but the exact time of last intake is unknown.
- To ensure a representative study population, the investigators will limit the number of patients who took DOACs within 24-48 hours before enrollment or those with unknown last intake time to 50% of the planned sample size. If this number is reached, the inclusion criterion 3 will be modified:
- DOACs intake within 24 hours prior to enrollment.
- Study intervention (IVT or placebo) can be started
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- within 4.5 hours of last known well (LKW). OR
- within 4.5 to 24 hours of LKW (including wake-up stroke) AND evidence of target mismatch profile on CT perfusion or MR perfusion (ischemic core volume < 50mL, hypoperfused volume to ischemic core volume ratio > 1.6, mismatch volume ≥10ml).
- Hypoperfused tissue is defined as Tmax >6s on CT perfusion or MR perfusion. Ischemic core is defined as rCBF <30% on CT perfusion or ADC<620μm^2/s on diffusion MRI.
- Baseline National Institutes of Health Stroke Scale (NIHSS) 4-25. OR Disabling stroke with baseline NIHSS of 0-3, including complete hemianopia, aphasia, measurable deficit on motor power, or other disabling neurological deficit judged by the investigator.
- Written informed consent signed by patients or their legally authorized representatives.
Who cannot join
- Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history.
- Allergic to tenecteplase.
- Pre-stroke mRS≥2
- Planned endovascular treatment.
- Currently on dual antiplatelet therapy in addition to DOAC therapy.
- Planned DOAC reversal treatment (including Idarucizumab, Andexanet and tranexamic acid).
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- Hypodensity on non-contrast CT estimates to be ≥ 1/3 MCA territory.
- Severe head trauma or other severe trauma in the last 3 months.
- Intracranial tumor, arteriovenous malformation and large-size aneurysm (≥10 mm) found before enrollment.
- Intracranial surgery, intraspinal surgery or other major surgeries within 3 months before enrollment (based on the assessment of the investigators)
- 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 × 10^9 /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 contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Yanting Chen, 86-20-81332619, chenyt367@mail.sysu.edu.cn
Xinguang Yang, yangxinguang0926@163.com
About this study
Official title: Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users (PEARL-DOAC): A Multicenter, Prospective, Randomized, Double-blinded, Placebo-controlled Trial
An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind trial to determine the efficacy and safety of intravenous tenecteplase thrombolysis in acute ischemic stroke (AIS) patients with recent direct oral anticoagulants (DOACs) intake in improving the 90-day functional outcome.
Read the detailed description
This study is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of intravenous tenecteplase thrombolysis in AIS patients with recent DOACs intake 48 hours prior to enrollment. 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 intervention group will receive tenecteplase administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach. All participants will receive standard medical treatment.
A total of 912 participants are anticipated to be recruited for this study, with 456 participants in each group (1:1 ratio).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Placebo
- 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 (TNK) (0.25 mg/kg, to maximum of 25mg)Drug
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization, and within 24 hours of stroke onset.
PlaceboDrug
Matched placebo is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization, and within 24 hours of stroke onset.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous tenecteplase | Experimental | Not described Receives: Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) |
| Matched placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 at 90 (±14) days.
Measured: 90 (±14) days
Secondary outcomes (6)
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS score 0-2 at 90 (±14) days.
Measured: 90 (±14) days
The modified Rankin Scale score (mRS) 0-3
The proportion of mRS score 0-3 at 90 (±14) days
Measured: 90 (±14) days
Level of disability
The shift analysis of the 90-day mRS with 5-6 merged at 90 (±14) days.
Measured: 90 (±14) days
The proportion of NIHSS 0-1 or ≥4 points reduction
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.
Measured: 24 (±12) hours
Quality of life (EQ-5D-5L)
Quality of life measured by EQ-5D-5L scale score at 90 (±14) days.
Measured: 90 (±14) days
Neurologic deficit (NIHSS score) changes
Neurologic deficit (NIHSS score) changes from baseline to 7 (±1) days or at discharge if earlier.
Measured: 7 (±1) days or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start14 Aug 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion31 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRaul G. Nogueira, Principal investigator, UPMC Stroke Institute, Departments of Neurology and Neurosurgery, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092709
- Sponsor's protocol ID
- SYSKY-2025-484-01
- Acronym
- PEARL-DOAC
- Status last verified
- Dec 2025
- First submitted
- 22 Jul 2025
- Last updated
- 16 Dec 2025
- 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 Principal Investigators (Prof. Yamei Tang and Prof. Raul G. Nogueira) upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users (PEARL-DOAC): A Multicenter, Prospective, Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07092709
- Acronym / sponsor ID
- PEARL-DOAC / SYSKY-2025-484-01
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jul 2025 (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.
An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind trial to determine the efficacy and safety of intravenous tenecteplase thrombolysis in acute ischemic stroke (AIS) patients with recent direct oral anticoagulants (DOACs) intake in improving the 90-day functional outcome.
Detailed description
This study is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of intravenous tenecteplase thrombolysis in AIS patients with recent DOACs intake 48 hours prior to enrollment. 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 intervention group will receive tenecteplase administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach. All participants will receive standard medical treatment.
A total of 912 participants are anticipated to be recruited for this study, with 456 participants in each group (1:1 ratio).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous tenecteplase | Experimental | Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) |
| Matched placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older.
- Clinically diagnosed with acute ischemic stroke.
- DOACs intake within 48 hours prior to enrollment, or on an ongoing DOACs therapy but the exact time of last intake is unknown.
- DOACs intake within 24 hours prior to enrollment.
- Study intervention (IVT or placebo) can be started
Key exclusion criteria (22 listed)
- Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history.
- Allergic to tenecteplase.
- Pre-stroke mRS≥2
- Planned endovascular treatment.
- Currently on dual antiplatelet therapy in addition to DOAC therapy.
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 (TNK) (0.25 mg/kg, to maximum of 25mg)Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization, and within 24 hours of stroke onset. | Drug | Intravenous tenecteplase |
| PlaceboMatched placebo is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization, and within 24 hours of stroke onset. | Drug | Matched placebo |
Primary outcome
The modified Rankin Scale score (mRS) 0-1
Time frame: 90 (±14) days
The proportion of mRS score 0-1 at 90 (±14) days.
6 secondary outcomes
The modified Rankin Scale score (mRS) 0-2
Time frame: 90 (±14) days
The modified Rankin Scale score (mRS) 0-3
Time frame: 90 (±14) days
Level of disability
Time frame: 90 (±14) days
The proportion of NIHSS 0-1 or ≥4 points reduction
Time frame: 24 (±12) hours
Quality of life (EQ-5D-5L)
Time frame: 90 (±14) days
Neurologic deficit (NIHSS score) changes
Time frame: 7 (±1) days or at discharge
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Raul G. Nogueira) 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 contact
Yamei Tang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Raul G. Nogueira principal investigator
UPMC Stroke Institute, Departments of Neurology and Neurosurgery, University of Pittsburgh
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 (TNK) (0.25 mg/kg, to maximum of 25mg) 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 11 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: looking for participants now, as of the sponsor's last update on 16 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. Some participants in this study may receive a placebo. 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 Yanting Chen (86-20-81332619, chenyt367@mail.sysu.edu.cn), or a site near the patient. 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 (±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 16 Dec 2025.