Acute Ischemic StrokePhase 2/3INSTANT-2NCT07842185
A Multicenter, Three-Arm, Open-Label, Endpoint-Blinded Randomized Controlled Trial to Evaluate the Optimal Duration of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
A Phase 2/3 study testing Tirofiban Injection in people with Acute Ischemic Stroke, run by Xinqiao Hospital of Chongqing at 10 sites in China.
Trial summary
Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tirofiban Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,482 participants
- Where
- 10 sitesChina
- Study dates
- 19 Nov 2026to 8 May 2031
- Phase
- Phase 2/3
- 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.
- Diagnosis of acute ischemic stroke meeting the diagnostic criteria from Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023, and the patient has received intravenous thrombolysis with tenecteplase, alteplase or reteplase.
- Disabling stroke remains at 2-24 hours after completion of intravenous thrombolysis. Disabling stroke is defined as NIHSS score ≥ 4, or single limb motor subscore ≥ 2.
- Written informed consent is obtained from the patient or legal representative.
Who cannot join
- Intracranial hemorrhage confirmed by CT or MRI after intravenous thrombolysis and prior to randomization.
- CTA/MRA/DSA demonstrates occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, anterior cerebral artery, or vertebrobasilar artery.
- History of atrial fibrillation or suspected cardioembolic stroke. Platelet count <100×10⁹/L on routine blood test.
- Renal insufficiency with estimated glomerular filtration rate (eGFR) <30 mL/min.
- Pregnant or breastfeeding women.
- Pre-existing neurological or psychiatric disorders that interfere with neurological function assessment.
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- History of bleeding disorders, severe cardiac, hepatic or renal disease, or sepsis.
- Brain tumor with mass effect on imaging (excluding small meningioma). Intracranial aneurysm or arteriovenous malformation (AVM).
- Advanced illness with life expectancy less than 6 months.
- Current participation in another clinical trial.
- Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Dalian Central Hospital
Dalian, Liaoning, 116000
Taihe County People's Hospital
Fuyang, Anhui, 236600
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000
Xingguo People's Hospital, Xinguo Hospital of Gannan Medical University
Ganzhou, Jiangxi, 342414
Jingdezhen First People's Hospital
Jingdezhen, Jiangxi, 333000
The First People's Hospital of Jingdezhen City
Jingdezhen, Jiangxi, 341000
Jiujiang First People's Hospital
Jiujiang, Jiangxi
Longyan First Hospital of Fujian Medical University
Longyan, Fujian, 364000
The First People's Hospital of Mianyang (Mianyang 404 Hospital)
Mianyang, Sichuan, 621000
Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
Xiangtan, Hunan, 411100
About this study
Official title: A Multicenter, Three-Arm, Open-Label, Endpoint-Blinded Randomized Controlled Trial to Evaluate the Optimal Infusion Duration of Early Tirofiban Treatment After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke (INSTANT-2)
Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. The reocclusion rate ranges from 14% to 34%, and many patients are left with residual neurological deficits. Early antiplatelet therapy initiated after thrombolysis may sustain persistent reperfusion and improve prognosis. However, current guidelines generally recommend delaying antiplatelet treatment until 24 hours post-thrombolysis due to bleeding risks, and direct evidence for the optimal initiation timing remains lacking. Tirofiban is a rapidly acting, short-half-life, reversible glycoprotein IIb/IIIa receptor antagonist. Previous studies indicate its potential benefits and acceptable safety when administered after intravenous thrombolysis.
This is a multicenter, three-arm, open-label, endpoint-blinded randomized controlled trial. A total of 1482 non-cardioembolic patients without large or medium vessel occlusion and with residual neurological deficits (NIHSS ≥4) after thrombolysis will be enrolled. Participants will be randomly allocated to the tirofiban 24-hour group, tirofiban 48-hour group, or blank control group. The primary outcome is the proportion of patients with excellent functional outcome defined as modified Rankin Scale (mRS) score 0-1 at 90 days. Symptomatic intracranial hemorrhage and neurological outcomes will also be evaluated. The study aims to determine the optimal duration of tirofiban treatment after thrombolysis and provide high-level evidence for precise interventions in the acute phase of stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban Injection, No Interventions
- Keywords
- Intravenous Thrombolysis, acute ischemic stroke, tirofiban, alteplase, 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.
Tirofiban InjectionDrug
Intravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 24 hours. The dosage regimen follows the trial protocol.
Tirofiban InjectionDrug
Intravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 48 hours. The dosage regimen follows the trial protocol.
No InterventionsOther
No tirofiban will be administered after intravenous thrombolysis. Patients receive routine standard clinical management according to hospital guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Tirofiban 24-hour group | Experimental | Arm A: Patients receive tirofiban for 24 hours after intravenous thrombolysis. Receives: Drug: Tirofiban Injection |
| Arm B: Tirofiban 48-hour group | Experimental | Arm B: Patients receive tirofiban for 48 hours after intravenous thrombolysis. Receives: Drug: Tirofiban Injection |
| Arm C: Standard care control group | Active comparator | No tirofiban is administered after intravenous thrombolysis. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mRS 0-1 at 90 days
Percentage of participants achieving modified Rankin Scale (mRS) score 0 or 1 at 90 days after randomization.
Measured: 90 days after randomization
Secondary outcomes (5)
mRS score at 90 days
Modified Rankin Scale (mRS) score assessed at 90 days after randomization.
Measured: 90 days after randomization
EQ-5D-5L score at 90 days
EQ-5D-5L questionnaire score assessed at 90 days after randomization.
Measured: 90 days after randomization
Proportion of patients with mRS 0-2 at 90 days
Percentage of participants achieving modified Rankin Scale (mRS) score 0 to 2 at 90 days after randomization.
Measured: 90 days after randomization
Proportion of patients with mRS 0-3 at 90 days
Percentage of participants achieving modified Rankin Scale (mRS) score 0 to 3 at 90 days after randomization.
Measured: 90 days after randomization
Proportion of early neurological improvement
Percentage of participants with early neurological improvement, defined as ≥30% reduction in NIHSS score at 48 hours post-randomization compared with the NIHSS score at randomization.
Measured: 48 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start19 Nov 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion8 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Ganzhou Hospital of Nanchang University
- Responsible party
- Principal investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
- Investigators
- zhongming qiu, Principal investigator, Xinqiao Hospital of the Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842185
- Sponsor's protocol ID
- INSTANT-2
- Acronym
- INSTANT-2
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified cleaned individual participant data (IPD) will be shared upon reasonable request after publication of the primary study results. All personal identifiers will be removed to protect participant privacy.
Publications
INSTANT Trial Authors for the INSTANT Investigators; Liu X, Zhang F, Zhang C, Li Z, Yuan G, Kong D, Xie S, Zhou M, Ye J, Lai Z, Li D, Xu H, Chen L, Cheng F, Shi Y, Chen B, Hu W, Liu H, Yin Y, Deng X, Xie Z, Li C, Shi J, Mei D, Liu B, Wang B, Zhou R, Liu J, Shen L, Hu H, Xiao G, Guan X, Yuan S, Lv X, Liang S, Zeng X, Chen Y, Cao W, Zheng C, Liu Y, Li J, Guan B, Lai T, Sun W, Zeng H, Zhang J, Li S, Sang H, Tang Y, Wang D, Lu M, Kaesmacher J, Yogendrakumar V, Pan S, Nogueira RG, Hong D, Goyal M, Thomalla G, Nguyen TN, Saver JL, Yang Q, Qiu Z, Zeng G. Intravenous Tirofiban After Tenecteplase in Acute Ischemic Stroke: The INSTANT Randomized Clinical Trial. JAMA. 2026 Jun 9;335(22):1949-1958. doi: 10.1001/jama.2026.5245.
PubMed 42100960
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Three-Arm, Open-Label, Endpoint-Blinded Randomized Controlled Trial to Evaluate the Optimal Infusion Duration of Early Tirofiban Treatment After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke (INSTANT-2)
- ClinicalTrials.gov ID
- NCT07842185
- Acronym / sponsor ID
- INSTANT-2 / INSTANT-2
- Conditions
- Acute Ischemic Stroke
- Keywords
- Intravenous Thrombolysis, acute ischemic stroke, tirofiban, alteplase, tenecteplase
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,482 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- The Affiliated Ganzhou Hospital of Nanchang University
- Study start
- 19 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 8 May 2031 (estimated)
- First posted
- 25 Sep 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.
Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. The reocclusion rate ranges from 14% to 34%, and many patients are left with residual neurological deficits. Early antiplatelet therapy initiated after thrombolysis may sustain persistent reperfusion and improve prognosis. However, current guidelines generally recommend delaying antiplatelet treatment until 24 hours post-thrombolysis due to bleeding risks, and direct evidence for the optimal initiation timing remains lacking. Tirofiban is a rapidly acting, short-half-life, reversible glycoprotein IIb/IIIa receptor antagonist. Previous studies indicate its potential benefits and acceptable safety when administered after intravenous thrombolysis.
This is a multicenter, three-arm, open-label, endpoint-blinded randomized controlled trial. A total of 1482 non-cardioembolic patients without large or medium vessel occlusion and with residual neurological deficits (NIHSS ≥4) after thrombolysis will be enrolled. Participants will be randomly allocated to the tirofiban 24-hour group, tirofiban 48-hour group, or blank control group. The primary outcome is the proportion of patients with excellent functional outcome defined as modified Rankin Scale (mRS) score 0-1 at 90 days. Symptomatic intracranial hemorrhage and neurological outcomes will also be evaluated. The study aims to determine the optimal duration of tirofiban treatment after thrombolysis and provide high-level evidence for precise interventions in the acute phase of stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Tirofiban 24-hour group | Experimental | Drug: Tirofiban InjectionArm A: Patients receive tirofiban for 24 hours after intravenous thrombolysis. |
| Arm B: Tirofiban 48-hour group | Experimental | Drug: Tirofiban InjectionArm B: Patients receive tirofiban for 48 hours after intravenous thrombolysis. |
| Arm C: Standard care control group | Active comparator | Other: No InterventionsNo tirofiban is administered after intravenous thrombolysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Diagnosis of acute ischemic stroke meeting the diagnostic criteria from Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023, and the patient has received intravenous thrombolysis with tenecteplase, alteplase or reteplase.
- Disabling stroke remains at 2-24 hours after completion of intravenous thrombolysis. Disabling stroke is defined as NIHSS score ≥ 4, or single limb motor subscore ≥ 2.
- Written informed consent is obtained from the patient or legal representative.
Key exclusion criteria (11 listed)
- Intracranial hemorrhage confirmed by CT or MRI after intravenous thrombolysis and prior to randomization.
- CTA/MRA/DSA demonstrates occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, anterior cerebral artery, or vertebrobasilar artery.
- History of atrial fibrillation or suspected cardioembolic stroke. Platelet count <100×10⁹/L on routine blood test.
- Renal insufficiency with estimated glomerular filtration rate (eGFR) <30 mL/min.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Tirofiban InjectionIntravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 24 hours. The dosage regimen follows the trial protocol. | Drug | Arm A: Tirofiban 24-hour group |
| Tirofiban InjectionIntravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 48 hours. The dosage regimen follows the trial protocol. | Drug | Arm B: Tirofiban 48-hour group |
| No InterventionsNo tirofiban will be administered after intravenous thrombolysis. Patients receive routine standard clinical management according to hospital guidelines. | Other | Arm C: Standard care control group |
Primary outcome
Proportion of patients with mRS 0-1 at 90 days
Time frame: 90 days after randomization
Percentage of participants achieving modified Rankin Scale (mRS) score 0 or 1 at 90 days after randomization.
5 secondary outcomes
mRS score at 90 days
Time frame: 90 days after randomization
EQ-5D-5L score at 90 days
Time frame: 90 days after randomization
Proportion of patients with mRS 0-2 at 90 days
Time frame: 90 days after randomization
Proportion of patients with mRS 0-3 at 90 days
Time frame: 90 days after randomization
Proportion of early neurological improvement
Time frame: 48 hours 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 25 Sep 2026.
- Results publication: PubMed 42100960INSTANT Trial Authors for the INSTANT Investigators; Liu X, Zhang F, Zhang C, Li Z, Yuan G, Kong D, Xie S, Zhou M, Ye J, Lai Z, Li D, Xu H, Chen L, Cheng F, Shi Y, Chen B, Hu W, Liu H, Yin Y, Deng X, Xie Z, Li C, Shi J, Mei D, Liu B, Wang B, Zhou R, Liu J, Shen L, Hu H, Xiao G, Guan X, Yuan S, Lv X, Liang S, Zeng X, Chen Y, Cao W, Zheng C, Liu Y, Li J, Guan B, Lai T, Sun W, Zeng H, Zhang J, Li S, Sang H, Tang Y, Wang D, Lu M, Kaesmacher J, Yogendrakumar V, Pan S, Nogueira RG, Hong D, Goyal M, Thomalla G, Nguyen TN, Saver JL, Yang Q, Qiu Z, Zeng G. Intravenous Tirofiban After Tenecteplase in Acute Ischemic Stroke: The INSTANT Randomized Clinical Trial. JAMA. 2026 Jun 9;335(22):1949-1958. doi: 10.1001/jama.2026.5245.
- Individual participant dataSharing planned: Yes. De-identified cleaned individual participant data (IPD) will be shared upon reasonable request after publication of the primary study results. All personal identifiers will be removed to protect participant privacy.
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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.
zhongming qiu principal investigator
Xinqiao Hospital of the Army Medical University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tirofiban Injection in people with Acute Ischemic Stroke, run by Xinqiao Hospital of Chongqing at 10 sites 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 4 inclusion and 11 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 combined 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.
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 Guoyong Zeng, doctor (+8613507079530, hsyygy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with mRS 0-1 at 90 days (time frame: 90 days after randomization). 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 NCT07842185, 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 25 Sep 2026.