StrokePhase 3RECLAIM-TNKNCT07471282
Reperfusion Completion Via Local Arterial Infusion of Tenecteplase After Incomplete Mechanical Thrombectomy
A Phase 3 study testing Tenecteplase (0.0938mg/kg) in people with Stroke, run by Chuansheng Zhao at 1 site in China.
Trial summary
To evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI < 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tenecteplase (0.0938mg/kg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Mar 2029
- 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;
- Time from symptom onset or last known well to randomization within 24 hours;
- Clinical diagnosis of acute ischemic stroke caused by acute occlusion of the intracranial anterior circulation large vessels confirmed by CTA/MRA/DSA, including occlusion of the intracranial segment of the internal carotid artery, the M1 or M2 segments of the middle cerebral artery, with or without concomitant occlusion of the ipsilateral extracranial segment of the internal carotid artery;
- NIHSS score ≥ 6, and meeting the current guidelines for mechanical thrombectomy;
- Anterior circulation large vessel stroke due to occlusion of the intracranial ICA, MCA M1, or M2 segments;
- Pre-stroke mRS score ≤ 1;
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- ASPECTS score ≥ 6;
- Post-mechanical thrombectomy status with 2b ≤ eTICI < 3, and the operator has decided not to attempt further mechanical recanalization of the occluded vessel;
- No more than 3 passes with the thrombectomy device;
- Signed informed consent obtained from the patient or their legal guardian.
Who cannot join
- Contraindications to intravenous thrombolysis (excluding time-based criteria);
- DSA post-thrombectomy indicating dissection of the occluded artery, or intra-procedural flat-panel CT suggesting local hemorrhage or significant contrast extravasation;
- Baseline NIHSS score not obtained;
- Severe allergy or absolute contraindication to iodinated contrast media;
- Systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg, refractory to antihypertensive medication;
- Blood glucose < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L);
Show all 16Show fewer
- Platelet count < 50 × 10⁹/L, or APTT > 40 s, or PT > 15 s;
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or current use of oral anticoagulants with INR > 1.7;
- Severe renal failure, defined as serum creatinine > 3.0 mg/dL (or 265.2 μmol/L) or glomerular filtration rate [GFR] < 30 mL/min, or requiring hemodialysis or peritoneal dialysis;
- Patient unlikely to complete the 90-day follow-up (e.g., no fixed address, palliative care patient, etc.);
- Suspected vasculitis or septic embolism;
- Suspected aortic dissection;
- Pre-existing neurological or psychiatric disease that would interfere with the assessment of outcomes;
- Pregnancy or lactation;
- Current participation in another clinical trial that could interfere with this study;
- Any other condition deemed by the investigator to make the patient unsuitable for participation or to pose a significant risk to the patient.
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
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Official title: Effectiveness and Safety of Intra-arterial Tenecteplase Bridging Therapy Following Incomplete Recanalization After Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
To evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI < 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion.
Read the detailed description
Stroke is a group of diseases characterized by neurological deficits resulting from ischemic or hemorrhagic damage to brain tissue. It has high rates of incidence, disability, and mortality, making it the leading cause of disability and a significant cause of death among residents in China, imposing a heavy disease burden on families and society. According to the "China Stroke Center Report 2020", there are approximately 17.8 million stroke survivors among people aged over 40 in China, with 3.4 million new cases annually. Among these, Acute Ischemic Stroke (AIS) accounts for up to 80%. Current common clinical treatment strategies for AIS include Standard Medical Therapy (SMT), which involves Intravenous Thrombolysis (IVT), and Endovascular Thrombectomy (EVT). Extensive clinical evidence has fully confirmed a significant positive correlation between reperfusion quality and patient prognosis, suggesting that adopting more aggressive strategies to optimize reperfusion may be of great significance.
Incomplete reperfusion may result from various causes, including distal microthrombi occluding the microvasculature, residual occlusion unreachable by mechanical devices during EVT, and the formation of new emboli. As these situations are typically not amenable to mechanical thrombectomy, intra-arterial thrombolytic therapy has emerged as a potential option to further improve reperfusion in ischemic tissue. The CHOICE study was the first international randomized controlled trial (RCT) on EVT bridging with intra-arterial thrombolysis. Its results indicated that the group receiving successful mechanical thrombectomy combined with intra-arterial alteplase had improved neurological outcomes in AIS patients with anterior circulation large vessel occlusion compared to the control group (90-day mRS 0-1, 59% vs. 40.0%, P=0.047), with no significant difference in bleeding risk between the two groups.
Subsequently, several other important related studies were published, including the PEARL study (also using alteplase), the ANGEL-TNK, POST-TNK, and DATE studies (using tenecteplase, TNK), and the POST-UK study (using urokinase). Due to differing patient selection criteria, the results varied. However, a careful comparison reveals that studies whose inclusion criteria comprised patients with eTICI 2b grade (i.e., incomplete recanalization) all yielded positive conclusions, including CHOICE, PEARL, and ANGEL-TNK. More importantly, a subgroup analysis of the ANGEL-TNK study clearly found that in the eTICI 2b group, patients receiving intra-arterial TNK had significantly better clinical outcomes than those in the medical therapy group (90-day mRS 0-1, 42.3% vs. 21.8%, RR=2.08, 95%CI 1.35-3.20, P<0.001), whereas no significant difference was observed between the two groups in the eTICI 2c/3 group. This suggests that intra-arterial TNK therapy may offer greater benefits in the population failing to achieve complete recanalization.
TNK, a genetically engineered variant of alteplase, features amino acid modifications at three key sites, which significantly prolong its half-life and enhance its fibrin-binding specificity. In recent years, it has emerged as one of the most promising novel thrombolytic agents in the field of stroke thrombolysis. Studies have found that in patients with LVO identified on baseline CTA, TNK thrombolysis achieves significantly higher recanalization rates compared to alteplase, indicating TNK's unique advantage for large vessel occlusion. Therefore, the therapeutic effect of EVT combined with intra-arterial TNK thrombolysis holds great potential for AIS patients with anterior circulation large vessel occlusion, particularly those with incomplete recanalization after EVT, but this requires further investigation and confirmation.
This study aims to evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI < 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion, using a prospective, multicenter, randomized, double-blind, placebo-controlled trial design.
- Conditions
- Stroke
- Being tested
- Tenecteplase (0.0938mg/kg), Placebo
- Keywords
- Ischemic Stroke with Large Vessel Occlusion, Tenecteplase, Incomplete Mechanical Thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenecteplase (0.0938mg/kg)Drug
Post-mechanical thrombectomy bridging therapy with intra-arterial tenecteplase (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI < 3).
PlaceboDrug
Post-mechanical thrombectomy bridging "therapy" with intra-arterial placebo (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI < 3).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Intra-arterial thrombolysis using placebo Receives: Drug: Placebo |
| Tenecteplase Group | Experimental | Intra-arterial thrombolysis using tenecteplase Receives: Drug: Tenecteplase (0.0938mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days
Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days
Measured: 3 months after randomization
Secondary outcomes (8)
Change in eTICI grade on cerebral angiography
Change in eTICI grade on cerebral angiography
Measured: Immediately after intra-arterial thrombolysis
Proportion of patients with mRS score 0-2 at 90 (±7) days
Proportion of patients with mRS score 0-2 at 90 (±7) days
Measured: 3 months after randomization
Proportion of patients with mRS score 0-3 at 90 (±7) days
Proportion of patients with mRS score 0-3 at 90 (±7) days
Measured: 3 months after randomization
mRS shift analysis at 90 (±7) days
mRS shift analysis at 90 (±7) days
Measured: 3 months after randomization
Proportion of patients with NIHSS score 0-1 or a decrease from baseline of ≥10 points at 48 (±12) hours
Proportion of patients with NIHSS score 0-1 or a decrease from baseline of ≥10 points at 48 (±12) hours
Measured: 48 hours after randomization
Change in NIHSS score at 7 (±1) days
Change in NIHSS score at 7 (±1) days
Measured: 7 days or discharge after randomization
EQ-5D scale score at 90 (±7) days
EQ-5D scale score at 90 (±7) days
Measured: 3 months after randomization
Barthel Index (BI) at 90 (±7) days
Barthel Index (BI) at 90 (±7) days
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, double-blind, placebo-controlled, 1:1 allocation, 90-day follow-up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuansheng Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuansheng Zhao, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471282
- Sponsor's protocol ID
- RECLAIM-TNK-2026
- Acronym
- RECLAIM-TNK
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Intra-arterial Tenecteplase Bridging Therapy Following Incomplete Recanalization After Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07471282
- Acronym / sponsor ID
- RECLAIM-TNK / RECLAIM-TNK-2026
- Conditions
- Stroke
- Keywords
- Ischemic Stroke with Large Vessel Occlusion, Tenecteplase, Incomplete Mechanical Thrombectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Chuansheng ZhaoUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 13 Mar 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.
To evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI < 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion.
Detailed description
Stroke is a group of diseases characterized by neurological deficits resulting from ischemic or hemorrhagic damage to brain tissue. It has high rates of incidence, disability, and mortality, making it the leading cause of disability and a significant cause of death among residents in China, imposing a heavy disease burden on families and society. According to the "China Stroke Center Report 2020", there are approximately 17.8 million stroke survivors among people aged over 40 in China, with 3.4 million new cases annually. Among these, Acute Ischemic Stroke (AIS) accounts for up to 80%. Current common clinical treatment strategies for AIS include Standard Medical Therapy (SMT), which involves Intravenous Thrombolysis (IVT), and Endovascular Thrombectomy (EVT). Extensive clinical evidence has fully confirmed a significant positive correlation between reperfusion quality and patient prognosis, suggesting that adopting more aggressive strategies to optimize reperfusion may be of great significance.
Incomplete reperfusion may result from various causes, including distal microthrombi occluding the microvasculature, residual occlusion unreachable by mechanical devices during EVT, and the formation of new emboli. As these situations are typically not amenable to mechanical thrombectomy, intra-arterial thrombolytic therapy has emerged as a potential option to further improve reperfusion in ischemic tissue. The CHOICE study was the first international randomized controlled trial (RCT) on EVT bridging with intra-arterial thrombolysis. Its results indicated that the group receiving successful mechanical thrombectomy combined with intra-arterial alteplase had improved neurological outcomes in AIS patients with anterior circulation large vessel occlusion compared to the control group (90-day mRS 0-1, 59% vs. 40.0%, P=0.047), with no significant difference in bleeding risk between the two groups.
Subsequently, several other important related studies were published, including the PEARL study (also using alteplase), the ANGEL-TNK, POST-TNK, and DATE studies (using tenecteplase, TNK), and the POST-UK study (using urokinase). Due to differing patient selection criteria, the results varied. However, a careful comparison reveals that studies whose inclusion criteria comprised patients with eTICI 2b grade (i.e., incomplete recanalization) all yielded positive conclusions, including CHOICE, PEARL, and ANGEL-TNK. More importantly, a subgroup analysis of the ANGEL-TNK study clearly found that in the eTICI 2b group, patients receiving intra-arterial TNK had significantly better clinical outcomes than those in the medical therapy group (90-day mRS 0-1, 42.3% vs. 21.8%, RR=2.08, 95%CI 1.35-3.20, P<0.001), whereas no significant difference was observed between the two groups in the eTICI 2c/3 group. This suggests that intra-arterial TNK therapy may offer greater benefits in the population failing to achieve complete recanalization.
TNK, a genetically engineered variant of alteplase, features amino acid modifications at three key sites, which significantly prolong its half-life and enhance its fibrin-binding specificity. In recent years, it has emerged as one of the most promising novel thrombolytic agents in the field of stroke thrombolysis. Studies have found that in patients with LVO identified on baseline CTA, TNK thrombolysis achieves significantly higher recanalization rates compared to alteplase, indicating TNK's unique advantage for large vessel occlusion. Therefore, the therapeutic effect of EVT combined with intra-arterial TNK thrombolysis holds great potential for AIS patients with anterior circulation large vessel occlusion, particularly those with incomplete recanalization after EVT, but this requires further investigation and confirmation.
This study aims to evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI < 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion, using a prospective, multicenter, randomized, double-blind, placebo-controlled trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized, double-blind, placebo-controlled, 1:1 allocation, 90-day follow-up.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: PlaceboIntra-arterial thrombolysis using placebo |
| Tenecteplase Group | Experimental | Drug: Tenecteplase (0.0938mg/kg)Intra-arterial thrombolysis using tenecteplase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years;
- Time from symptom onset or last known well to randomization within 24 hours;
- Clinical diagnosis of acute ischemic stroke caused by acute occlusion of the intracranial anterior circulation large vessels confirmed by CTA/MRA/DSA, including occlusion of the intracranial segment of the internal carotid artery, the M1 or M2 segments of the middle cerebral artery, with or without concomitant occlusion of the ipsilateral extracranial segment of the internal carotid artery;
- NIHSS score ≥ 6, and meeting the current guidelines for mechanical thrombectomy;
- Anterior circulation large vessel stroke due to occlusion of the intracranial ICA, MCA M1, or M2 segments;
Key exclusion criteria (16 listed)
- Contraindications to intravenous thrombolysis (excluding time-based criteria);
- DSA post-thrombectomy indicating dissection of the occluded artery, or intra-procedural flat-panel CT suggesting local hemorrhage or significant contrast extravasation;
- Baseline NIHSS score not obtained;
- Severe allergy or absolute contraindication to iodinated contrast media;
- Systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg, refractory to antihypertensive medication;
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 (0.0938mg/kg)Post-mechanical thrombectomy bridging therapy with intra-arterial tenecteplase (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI < 3). | Drug | Tenecteplase Group |
| PlaceboPost-mechanical thrombectomy bridging "therapy" with intra-arterial placebo (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI < 3). | Drug | Placebo Group |
Primary outcome
Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days
Time frame: 3 months after randomization
Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days
8 secondary outcomes
Change in eTICI grade on cerebral angiography
Time frame: Immediately after intra-arterial thrombolysis
Proportion of patients with mRS score 0-2 at 90 (±7) days
Time frame: 3 months after randomization
Proportion of patients with mRS score 0-3 at 90 (±7) days
Time frame: 3 months after randomization
mRS shift analysis at 90 (±7) days
Time frame: 3 months after randomization
Proportion of patients with NIHSS score 0-1 or a decrease from baseline of ≥10 points at 48 (±12) hours
Time frame: 48 hours after randomization
Change in NIHSS score at 7 (±1) days
Time frame: 7 days or discharge after randomization
EQ-5D scale score at 90 (±7) days
Time frame: 3 months after randomization
Barthel Index (BI) at 90 (±7) days
Time frame: 3 months after randomization
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 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Tenecteplase (0.0938mg/kg) in people with Stroke, run by Chuansheng Zhao 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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 13 Mar 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. 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 Haoyue Zhu (+86-15940220919, zhuhaoyuejason@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days (time frame: 3 months after randomization). 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 13 Mar 2026.