Acute Ischemic StrokePhase 3IA-TirofibanNCT07537933
Intra-Arterial Tirofiban After Complete Recanalization for Acute Intracranial Large-Vessel Occlusion
A Phase 3 study testing Tirofiban in people with Acute Ischemic Stroke and Large-vessel Occlusion, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Large-vessel Occlusion, Endovascular Treatment
- What is being tested?
- Tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Apr 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; Last known well to arterial puncture within 0 to 24 hours; Preoperative imaging confirms anterior circulation large-vessel occlusion, including intracranial internal carotid artery occlusion or middle cerebral artery M1 or dominant M2 occlusion; Baseline National Institutes of Health Stroke Scale (NIHSS) score 6 to 25; Baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on CT or DWI; Pre-stroke modified Rankin Scale (mRS) score ≤1; eTICI 2c to 3 complete recanalization achieved after mechanical thrombectomy, or spontaneous recanalization to eTICI 2c to 3 confirmed intraoperatively without further thrombectomy; Embolic occlusion with no residual fixed stenosis in the target vessel after thrombectomy; Written informed consent provided by the participant or legally authorized representative.
Who cannot join
- Pregnancy or breastfeeding; Active bleeding within the previous month or known severe bleeding tendency; Major underlying disease with life expectancy <6 months, or inability in the investigator's judgment to complete follow-up; Participation in another interventional clinical trial; Use of oral anticoagulants within 48 hours before symptom onset with INR >1.7, or recent use of direct oral anticoagulants not meeting institutional cessation or testing requirements; Platelet count <50 × 10^9/L; Blood glucose <2.8 mmol/L or >22.2 mmol/L that cannot be corrected promptly Severe renal insufficiency, defined as eGFR <30 mL/min/1.73 m² or serum creatinine >2.5 mg/dL; Uncontrolled blood pressure, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg despite treatment; Imaging evidence of intracranial hemorrhage, or presence of an intracranial aneurysm, arteriovenous malformation, brain tumor, or other lesion associated with high bleeding risk; Bilateral acute cerebral infarction or multiple intracranial arterial occlusions Intraoperative vessel rupture, dissection, contrast extravasation, or other severe complications requiring a change in the standard anticoagulation strategy; Need for balloon angioplasty, permanent stent placement, or planned initiation of antiplatelet or anticoagulation therapy within 24 hours after the procedure; More than 3 thrombectomy passes or puncture-to-recanalization time >90 minutes; Use of an intraoperative intravenous heparin bolus, excluding heparinized saline flush; Suspected embolic stroke due to infection or infectious endocarditis; Severe allergy to contrast agents or tirofiban.
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
Shandong Provincial Hospital, Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
Qinjian Sun, MD, +86-68773274, qjsun@email.sdfmu.edu.cn
About this study
Official title: Efficacy and Safety of Immediate Intra-Arterial Tirofiban After Mechanical Thrombectomy Recanalization in Acute Intracranial Large-Vessel Occlusion
The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. The main questions it aims to answer are:
Does immediate intra-arterial tirofiban after complete recanalization increase the number of participants with good functional outcome at 90 days? Does this treatment increase the risk of symptomatic intracranial hemorrhage or other important bleeding events?
Read more
Researchers will compare immediate intra-arterial tirofiban with no intra-arterial tirofiban after complete recanalization to see if tirofiban improves recovery and is safe.
Participants will:
Be enrolled after mechanical thrombectomy achieves complete recanalization Be randomly assigned to receive intra-arterial tirofiban or no intra-arterial tirofiban Receive follow-up assessments during hospitalization and at 90 days
- Being tested
- Tirofiban
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Immediate intra-arterial tirofiban (0.5 mg) infusion administered after achieving eTICI 2c-3 complete recanalization in patients with acute ischemic stroke due to large-vessel occlusion. The infusion is delivered over 10 minutes (1 mL/min).
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial Tirofiban Treatment | Experimental | Participants in this arm will receive immediate intra-arterial tirofiban (0.5 mg) infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. The infusion will be administered over 10 minutes (1 mL/min) at the time of complete recanalization. Receives: Drug: Tirofiban |
| No Intra-arterial Tirofiban Treatment | No intervention | Participants in this arm will receive no intra-arterial tirofiban infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. Standard care will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days
The primary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90±7 days, indicating functional independence after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion
Measured: 90±7 Days
Secondary outcomes (7)
Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days
The secondary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90±7 days, indicating mild disability after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion.
Measured: 90±7 days
Proportion of Participants with mRS 0-3 at 90±7 Days
This secondary outcome measures the proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 90±7 days, indicating moderate disability
Measured: 90±7 Days
Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours
This secondary outcome evaluates the incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours after treatment.
Measured: 48 hours
Any Intracranial Hemorrhage (ICH) within 48 Hours
This outcome measures the occurrence of any intracranial hemorrhage (ICH) within 48 hours following the intervention
Measured: 48 hours
90-Day All-Cause Mortality
This secondary outcome evaluates the all-cause mortality rate at 90±7 days.
Measured: 90±7 days
Early Neurological Improvement (≥10-point decrease in NIHSS) at 48 hours
Early neurological improvement is defined as a decrease of 10 or more points from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 48 hours after treatment. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological impairment and a worse outcome.
Measured: 48 hours
Health-Related Quality of Life at 90±7 Days
Health-related quality of life will be measured at 90±7 days using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Scores range from -0.39 to 1, with higher scores indicating better quality of life.
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 posted17 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 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.
- 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
- For the Interventional Study Model, participants will be randomly assigned to one of two groups: Experimental Group: Receive intra-arterial tirofiban immediately after achieving complete recanalization (eTICI 2c-3). Control Group: No intra-arterial tirofiban administered.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qinjian Sun, MD, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537933
- Sponsor's protocol ID
- IA-Tirofiban-2026-1012
- Other IDs
- SWYX:NO. 2026-1012
- Acronym
- IA-Tirofiban
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 22 Apr 2026
- 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. Qinjian Sun) upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Immediate Intra-Arterial Tirofiban After Mechanical Thrombectomy Recanalization in Acute Intracranial Large-Vessel Occlusion
- ClinicalTrials.gov ID
- NCT07537933
- Acronym / sponsor ID
- IA-Tirofiban / IA-Tirofiban-2026-1012
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Apr 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.
The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. The main questions it aims to answer are:
Does immediate intra-arterial tirofiban after complete recanalization increase the number of participants with good functional outcome at 90 days? Does this treatment increase the risk of symptomatic intracranial hemorrhage or other important bleeding events?
Researchers will compare immediate intra-arterial tirofiban with no intra-arterial tirofiban after complete recanalization to see if tirofiban improves recovery and is safe.
Participants will:
Be enrolled after mechanical thrombectomy achieves complete recanalization Be randomly assigned to receive intra-arterial tirofiban or no intra-arterial tirofiban Receive follow-up assessments during hospitalization and at 90 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For the Interventional Study Model, participants will be randomly assigned to one of two groups: Experimental Group: Receive intra-arterial tirofiban immediately after achieving complete recanalization (eTICI 2c-3). Control Group: No intra-arterial tirofiban administered.
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial Tirofiban Treatment | Experimental | Drug: TirofibanParticipants in this arm will receive immediate intra-arterial tirofiban (0.5 mg) infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. The infusion will be administered over 10 minutes (1 mL/min) at the time of complete recanalization. |
| No Intra-arterial Tirofiban Treatment | No intervention | –Participants in this arm will receive no intra-arterial tirofiban infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. Standard care will be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years; Last known well to arterial puncture within 0 to 24 hours; Preoperative imaging confirms anterior circulation large-vessel occlusion, including intracranial internal carotid artery occlusion or middle cerebral artery M1 or dominant M2 occlusion; Baseline National Institutes of Health Stroke Scale (NIHSS) score 6 to 25; Baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on CT or DWI; Pre-stroke modified Rankin Scale (mRS) score ≤1; eTICI 2c to 3 complete recanalization achieved after mechanical thrombectomy, or spontaneous recanalization to eTICI 2c to 3 confirmed intraoperatively without further thrombectomy; Embolic occlusion with no residual fixed stenosis in the target vessel after thrombectomy; Written informed consent provided by the participant or legally authorized representative.
Key exclusion criteria (1 listed)
- Pregnancy or breastfeeding; Active bleeding within the previous month or known severe bleeding tendency; Major underlying disease with life expectancy <6 months, or inability in the investigator's judgment to complete follow-up; Participation in another interventional clinical trial; Use of oral anticoagulants within 48 hours before symptom onset with INR >1.7, or recent use of direct oral anticoagulants not meeting institutional cessation or testing requirements; Platelet count <50 × 10^9/L; Blood glucose <2.8 mmol/L or >22.2 mmol/L that cannot be corrected promptly Severe renal insufficiency, defined as eGFR <30 mL/min/1.73 m² or serum creatinine >2.5 mg/dL; Uncontrolled blood pressure, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg despite treatment; Imaging evidence of intracranial hemorrhage, or presence of an intracranial aneurysm, arteriovenous malformation, brain tumor, or other lesion associated with high bleeding risk; Bilateral acute cerebral infarction or multiple intracranial arterial occlusions Intraoperative vessel rupture, dissection, contrast extravasation, or other severe complications requiring a change in the standard anticoagulation strategy; Need for balloon angioplasty, permanent stent placement, or planned initiation of antiplatelet or anticoagulation therapy within 24 hours after the procedure; More than 3 thrombectomy passes or puncture-to-recanalization time >90 minutes; Use of an intraoperative intravenous heparin bolus, excluding heparinized saline flush; Suspected embolic stroke due to infection or infectious endocarditis; Severe allergy to contrast agents or tirofiban.
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 |
|---|---|---|
| TirofibanImmediate intra-arterial tirofiban (0.5 mg) infusion administered after achieving eTICI 2c-3 complete recanalization in patients with acute ischemic stroke due to large-vessel occlusion. The infusion is delivered over 10 minutes (1 mL/min). | Drug | Intra-arterial Tirofiban Treatment |
Primary outcome
Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days
Time frame: 90±7 Days
The primary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90±7 days, indicating functional independence after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion
7 secondary outcomes
Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days
Time frame: 90±7 days
Proportion of Participants with mRS 0-3 at 90±7 Days
Time frame: 90±7 Days
Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours
Time frame: 48 hours
Any Intracranial Hemorrhage (ICH) within 48 Hours
Time frame: 48 hours
90-Day All-Cause Mortality
Time frame: 90±7 days
Early Neurological Improvement (≥10-point decrease in NIHSS) at 48 hours
Time frame: 48 hours
Health-Related Quality of Life at 90±7 Days
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 22 Apr 2026.
- Individual participant dataSharing planned: Yes. The IPD will be available from Principal Investigators (Prof. Qinjian Sun) 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.
Qinjian Sun, MD principal investigator
Shandong Provincial Hospital
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 Tirofiban in people with Acute Ischemic Stroke and Large-vessel Occlusion, run by Shandong Provincial Hospital 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 1 inclusion and 1 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 22 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 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 Wang Chen, MD (+86-68773274, chenwang@sph.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days (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 22 Apr 2026.