Ischemic StrokePhase 2RITIS-TNKNCT07375953
Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)
A Phase 2 study testing Tenecteplase in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tenecteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 30 Dec 2027
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year;
- Acute ischemic stroke within 3 hours of onset, having received standard intravenous thrombolysis;
- Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
- No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis, with intracranial hemorrhage ruled out by neuroimaging;
- The second intravenous thrombolysis can be administered within 4.5 hours of onset;
- First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
- Signed informed consent.
Who cannot join
- Planed for endovascular treatment;
- Significant cerebral white matter hyperintensities (Fazekas score 3)；
- Any coagulation abnormality before the first thrombolysis, including INR > 1.5；
- Pregnancy；
- Allergy to the investigational drug(s)；
- Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis;
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- Comorbidity with other serious diseases;
- Participating in other clinical trials within 3 months;
- Patients not suitable for the study considered by researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yu Cui
Shenyang, None Selected, 110840
Yu Cui, 02428897499, cuiyu.spu@hotmail.com
About this study
Official title: Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study
Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant proportion of patients fail to achieve early clinical improvement after standard thrombolysis, likely due to persistent vessel occlusion.
This study proposes to investigate a rescue strategy for patients who do not show significant neurological improvement within one hour after receiving standard intravenous tenecteplase within 3 hours of stroke onset. The primary objective is to evaluate the safety and feasibility of administering a second dose of tenecteplase in this scenario. The study will also explore the potential efficacy of this approach in improving recanalization and functional outcomes.
- Conditions
- Ischemic Stroke
- Being tested
- 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.
TenecteplaseDrug
Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| TNK group | Experimental | Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg. Receives: Drug: Tenecteplase |
| Control group | No intervention | No tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 90±7 days
Secondary outcomes (11)
proportion of modified Rankin Scale (mRS) 0-2
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 90±7 days
ordinal distribution of modified Rankin Scale (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 90±7 days
occurrence of early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score (NIHSS); the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Measured: 24 (-6/+12) hours
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of National Institute of Health stroke scale (NIHSS) are 0 and 42, respectively; higher NIHSS score mean a worse outcome
Measured: 24 (-6/+12) hours
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of National Institute of Health stroke scale (NIHSS) are 0 and 42, respectively; higher NIHSS score mean a worse outcome
Measured: 10±2 days
new stroke or other vascular event(s)
Measured: 90±7 days
symptomatic intracranial hemorrhage (sICH)
Measured: 24 (-6/+12) hours
any intracranial hemorrhage
Measured: 24 (-6/+12) hours
major systemic bleeding event
Measured: 24 (-6/+12) hours
any bleeding event
Measured: 24 (-6/+12) hours
all-cause mortality
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.
- First posted29 Jan 2026
- Study start25 Mar 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375953
- Sponsor's protocol ID
- Y (2025) 501
- Acronym
- RITIS-TNK
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study
- ClinicalTrials.gov ID
- NCT07375953
- Acronym / sponsor ID
- RITIS-TNK / Y (2025) 501
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Jan 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.
Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant proportion of patients fail to achieve early clinical improvement after standard thrombolysis, likely due to persistent vessel occlusion.
This study proposes to investigate a rescue strategy for patients who do not show significant neurological improvement within one hour after receiving standard intravenous tenecteplase within 3 hours of stroke onset. The primary objective is to evaluate the safety and feasibility of administering a second dose of tenecteplase in this scenario. The study will also explore the potential efficacy of this approach in improving recanalization and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNK group | Experimental | Drug: TenecteplaseTenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg. |
| Control group | No intervention | –No tenecteplase |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 year;
- Acute ischemic stroke within 3 hours of onset, having received standard intravenous thrombolysis;
- Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
- No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis, with intracranial hemorrhage ruled out by neuroimaging;
- The second intravenous thrombolysis can be administered within 4.5 hours of onset;
Key exclusion criteria (9 listed)
- Planed for endovascular treatment;
- Significant cerebral white matter hyperintensities (Fazekas score 3)；
- Any coagulation abnormality before the first thrombolysis, including INR > 1.5；
- Pregnancy；
- Allergy to the investigational drug(s)；
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 |
|---|---|---|
| TenecteplaseTenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg. | Drug | TNK group |
Primary outcome
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
Time frame: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
11 secondary outcomes
proportion of modified Rankin Scale (mRS) 0-2
Time frame: 90±7 days
ordinal distribution of modified Rankin Scale (mRS)
Time frame: 90±7 days
occurrence of early neurological improvement (ENI)
Time frame: 24 (-6/+12) hours
change in National Institute of Health stroke scale (NIHSS) score
Time frame: 24 (-6/+12) hours
change in National Institute of Health stroke scale (NIHSS) score
Time frame: 10±2 days
new stroke or other vascular event(s)
Time frame: 90±7 days
symptomatic intracranial hemorrhage (sICH)
Time frame: 24 (-6/+12) hours
any intracranial hemorrhage
Time frame: 24 (-6/+12) hours
major systemic bleeding event
Time frame: 24 (-6/+12) hours
any bleeding event
Time frame: 24 (-6/+12) hours
all-cause mortality
Time frame: 90±7 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 1 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenecteplase in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region 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 7 inclusion and 9 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 1 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of excellent functional outcome (modified Rankin Scale (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?
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 1 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.