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Ischemic StrokePhase 2RITIS-TNK2NCT07375966

Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2)

A Phase 2 study testing Tenecteplase in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

While intravenous thrombolysis (IVT) within 4.5 hours is the standard medical reperfusion therapy, its efficacy is limited, particularly for large or medium vessel occlusions (LVO/MeVO), with low recanalization rates for IVT with rt-PA. 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
198 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 presumably caused by large or medium vessel occlusion within 4.5 hours of onset, having received standard-dose intravenous thrombolysis, and with no planned thrombectomy;
  • Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
  • Baseline pc-ASPECTS/ASPECTS ≥ 6, and for posterior circulation infarction, a Pontine-Midbrain Index ≤ 2 (assessed by CT or DWI);
  • No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis;
  • Follow-up imaging (CTA or MRA) at 1 hour after the first thrombolysis rules out intracranial hemorrhage and confirms the presence of large or medium vessel occlusion (internal carotid artery, M1-M3 segments of the middle cerebral artery, A1-A3 segments of the anterior cerebral artery, P1-P3 segments of the posterior cerebral artery, basilar artery or V4 segment of the vertebral artery, PICA, AICA, or SCA);
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  • The second intravenous thrombolysis can be administered within 6 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 white matter hyperintensities (Fazekas score 3);
  • Any coagulation abnormality before the first thrombolysis, including INR > 1.5;
  • Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis.；
  • Pregnancy；
  • Allergy to the investigational drug(s)；
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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

  • Lu Wang

    Shenyang, Liaoning, 110840

    Yu Cui, 862428897491, cuiyu.spu@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study

While intravenous thrombolysis (IVT) within 4.5 hours is the standard medical reperfusion therapy, its efficacy is limited, particularly for large or medium vessel occlusions (LVO/MeVO), with low recanalization rates for IVT with rt-PA. The newer thrombolytic agent, tenecteplase (TNK), offers practical advantages-including single bolus administration, a longer half-life, and potentially higher fibrin specificity-and has been shown to be non-inferior to rt-PA.

Despite advances, a significant proportion of patients with LVO/MeVO do not achieve early clinical improvement after standard IVT, likely due to persistent occlusion from a high thrombus burden. Endovascular therapy, while highly effective for LVO, has limited accessibility. Therefore, there is an urgent need for more effective and widely accessible pharmacological strategies.

This study proposes a rescue strategy based on the hypothesis that a second dose of IVT may improve outcomes in patients with imaging-confirmed LVO or MeVO who show no significant neurological improvement one hour after standard TNK thrombolysis (administered within 4.5 hours of stroke onset). The primary aim of this study is to formally evaluate the efficacy and safety of a repeated dose of intravenous tenecteplase in this specific patient population.

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 groups in NCT07375966
Study groupRoleWhat they receive
TNK groupExperimentalTenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.
Receives: Drug: Tenecteplase
Control groupNo interventionno tenecteplase

What is being measured

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

  1. rate of vessel recanalization

    Measured: 24 (-6/+12) hours

Secondary outcomes (11)

  1. 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

  2. proportion of favorable functional outcome (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

  3. 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

  4. occurrence of early neurological improvement (ENI)

    ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score; the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

    Measured: 24 (-6/+12) hours

  5. change in National Institute of Health stroke scale (NIHSS) score

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

    Measured: 24 (-6/+12) hours

  6. change in National Institute of Health stroke scale (NIHSS) score

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

    Measured: 10±2 days

  7. all-cause mortality

    Measured: 10±2 days

  8. occurence of symptomatic intracranial hemorrhage (sICH)

    Measured: 24 (-6/+12) hours

  9. occurence of any intracranial hemorrhage

    Measured: 24 (-6/+12) hours

  10. occurence of major systemic bleeding event

    Measured: 24 (-6/+12) hours

  11. occurence of any bleeding event

    Measured: 24 (-6/+12) hours

Timeline

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

  1. First posted29 Jan 2026
  2. Study start25 Mar 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07375966
Sponsor's protocol ID
Y (2025) 502
Acronym
RITIS-TNK2
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

Publications

  • Yao ZG, Chen MR, Wang L, Wang YH, Zhou ZH, Chen HS. Repeated intravenous thrombolysis for ischaemic stroke with medium to large vessel occlusion presenting within 4.5 hours of onset with tenecteplase in China (RITIS-TNK2): protocol for a prospective, randomised, open-label, blinded assessment of outcome and multicentre study. BMJ Open. 2026 Aug 21;16(8):e120918. doi: 10.1136/bmjopen-2026-120918.

    PubMed 42629154

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 9 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?

rate of vessel recanalization (time frame: 24 (-6/+12) hours). 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 NCT07375966, 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 1 Apr 2026.

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