Stroke, IschemicPhase 3NCT05657457

Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)

A Phase 3 study testing Tenecteplase in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Ischemic
What is being tested?: Tenecteplase
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 1 siteChina
Study dates: 21 Mar 2023to 18 May 2025
Phase: Phase 3
Are there results?: None posted in the registry

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
Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
Successful recanalization (mTICI 2b-3) after endovascular treatment;
PC-ASPECTS ≥ 6 on CT;
Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
Modified Rankin Scale score before stroke onset ≤ 3;
Signed informed consent by patient or their legally authorized representative.

Who cannot join

baseline PC ASPECTS < 5 on CT;
More than six retrieval attempts in the same vessel;
Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (<100000/mm3), or INR > 1.7;
Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;

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Patients with contraindication or allergic to any ingredient of drugs in our study
Pregnancy, plan to get pregnant or during lactation
The estimated life expectancy is less than 6 months due to other serious diseases;
Other conditions unsuitable for this clinical study assessed by researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

General Hospital of Northern Theater Command
Shenyang, 110840

Other trials in China

About this study

Official title: Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT): a Prospective, Randomized, Open-label, Blinded-end Point, Multicenter Trial

The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.

Conditions: Stroke, Ischemic
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
intra-arterial tenecteplase

Study groups in NCT05657457
Study group	Role	What they receive
TNK group	Experimental	Not described Receives: Drug: Tenecteplase
control group	No intervention	Not described

What is being measured

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

proportion of favorable functional outcome
favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3
Measured: Day 90

Secondary outcomes (15)

proportion of patients with an improved modified thrombolysis in cerebral infarction score
Measured: immediately after intraarterial TNK administration or at the end of endovascular treatment
the proportion of patients with modified Rankin Score (mRS) 0 to 1
mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
Measured: Day 90
the proportion of patients with modified Rankin Score (mRS) 0 to 2
mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
Measured: Day 90
ordinal distribution of modified Rankin Score (mRS)
mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
Measured: Day 90
change in modified Rankin Score (mRS) compared with premorbid mRS
mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
Measured: Day 90
change in National Institute of Health stroke scale (NIHSS)
NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit
Measured: 24 (-6/+24) hours
proportion of early neurological improvement
early neurological improvement is defined as a NIHSS decrease ≥4
Measured: 24 (-6/+24) hours
change in the cerebral circulation time
Measured: immediately after tenecteplase
the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events
Measured: Day 90
proportion of sympomatic intracranial hemorrhage
sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage
Measured: 24 (-6/+24) hours
proportion of intraparenchymal hemorrhage
intraparenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
Measured: 24 (-6/+24) hours
the percentage of severe adverse events
Measured: 24 (-6/+24) hours
cerebral edema
cerebral edema was measure by the mount of midline shift of the brain on neuroimaging
Measured: 24 (-6/+24) hours
all-cause mortality
Measured: 10 days
the number of tenecteplase infusions interrupted due to suspected active bleeding
Measured: during endovascular treatment (up to 2 hours)

Timeline

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

21 Mar 202318 May 2025

First posted20 Dec 2022
Study start21 Mar 2023
Primary completion18 May 2025
Study completion18 May 2025

Why it stopped: The interim analysis showed the potential harm of intra-arterial TNK.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stroke, IschemicStudies 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05657457
Sponsor's protocol ID: Y (2022) 185
Status last verified: Jul 2025
First submitted: 2 Dec 2022
Last updated: 2 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke, Ischemic trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT): a Prospective, Randomized, Open-label, Blinded-end Point, Multicenter Trial
ClinicalTrials.gov ID: NCT05657457
Acronym / sponsor ID: Y (2022) 185
Conditions: Stroke, Ischemic
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The interim analysis showed the potential harm of intra-arterial TNK.
Enrolment: 145 participants (actual)
Lead sponsor: General Hospital of Shenyang Military RegionUniversity, hospital or other
Collaborators: Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
Study start: 21 Mar 2023 (actual)
Primary completion: 18 May 2025 (actual)
Study completion: 18 May 2025 (actual)
First posted: 20 Dec 2022 (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.

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: Tenecteplase
control group	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age ≥ 18
Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
Successful recanalization (mTICI 2b-3) after endovascular treatment;
PC-ASPECTS ≥ 6 on CT;

Key exclusion criteria (10 listed)

baseline PC ASPECTS < 5 on CT;
More than six retrieval attempts in the same vessel;
Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (<100000/mm3), or INR > 1.7;
Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;

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
Tenecteplaseintra-arterial tenecteplase	Drug	TNK group

Primary outcome

proportion of favorable functional outcome
Time frame: Day 90
favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3

15 secondary outcomes

proportion of patients with an improved modified thrombolysis in cerebral infarction score
Time frame: immediately after intraarterial TNK administration or at the end of endovascular treatment
the proportion of patients with modified Rankin Score (mRS) 0 to 1
Time frame: Day 90
the proportion of patients with modified Rankin Score (mRS) 0 to 2
Time frame: Day 90
ordinal distribution of modified Rankin Score (mRS)
Time frame: Day 90
change in modified Rankin Score (mRS) compared with premorbid mRS
Time frame: Day 90
change in National Institute of Health stroke scale (NIHSS)
Time frame: 24 (-6/+24) hours
proportion of early neurological improvement
Time frame: 24 (-6/+24) hours
change in the cerebral circulation time
Time frame: immediately after tenecteplase
the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events
Time frame: Day 90
proportion of sympomatic intracranial hemorrhage
Time frame: 24 (-6/+24) hours
proportion of intraparenchymal hemorrhage
Time frame: 24 (-6/+24) hours
the percentage of severe adverse events
Time frame: 24 (-6/+24) hours
cerebral edema
Time frame: 24 (-6/+24) hours
all-cause mortality
Time frame: 10 days
the number of tenecteplase infusions interrupted due to suspected active bleeding
Time frame: during endovascular treatment (up to 2 hours)

Results and safety

The study was stopped early (reason given: The interim analysis showed the potential harm of intra-arterial TNK.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Individual participant dataSharing planned: Undecided

Related trials for Stroke, Ischemic

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 in people with Stroke, Ischemic, 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Jul 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. 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?

The study was stopped early (reason given: The interim analysis showed the potential harm of intra-arterial TNK.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of favorable functional outcome (time frame: Day 90). 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 NCT05657457.

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 2 Jul 2025.