Ischemic Stroke, AcutePhase 4NCT07760922
Tirofiban Combined With Aspirin in Moderate Ischemic Stroke
A Phase 4 study testing Tirofiban in people with Ischemic Stroke, Acute, run by Xinqiao Hospital of Chongqing at 5 sites in China.
Trial summary
Ischemic stroke accounts for the majority of stroke cases in China, and moderate ischemic stroke (NIHSS 4-10) carries a high risk of early neurologic deterioration (END) and long-term disability. Although intensified antiplatelet strategies reduce END, they have not consistently improved long-term functional outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Tirofiban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,168 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Phase 4
- 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 18-80 years;
- Acute ischemic stroke; time from last known well to randomization ≤ 24 hours;
- Pre-randomization NIHSS score 4-10, with at least one of item 5 (upper limb) or item 6 (lower limb) ≥ 1;
- Pre-stroke modified Rankin Scale (mRS) ≤ 1;
- Written informed consent provided by the patient or a legally authorized representative.
Who cannot join
- Intracranial hemorrhage confirmed by CT or MRI;
- Has received or is planned to receive reperfusion therapy (thrombolysis or endovascular treatment);
- Any definite cardioembolic source: chronic/paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction < 30%;
- Definite indication for anticoagulation (atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism);
- Severe systemic disease (e.g., severe infection, severe hepatic or renal dysfunction);
- Allergy to tirofiban and/or aspirin;
Show all 19Show fewer
- History of intracranial hemorrhage;
- Planned use of NSAIDs affecting platelet function;
- Gastrointestinal bleeding or major surgery within the past 3 months;
- Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months;
- Planned surgery or intervention requiring discontinuation of antiplatelet therapy;
- Stroke caused by angiography or surgery;
- Prior non-atherosclerotic arterial disease, including moyamoya disease, arterial dissection, fibromuscular dysplasia;
- Other structural brain disease (vascular malformation, tumor, abscess, multiple sclerosis, etc.) confirmed by CT/MRI;
- Pregnancy or lactation;
- Prior neurologic or psychiatric disease that would interfere with neurologic assessment;
- Participation in another clinical trial;
- Advanced disease with expected survival < 6 months;
- Expected inability to complete follow-up.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jing Lin, MD contact
5 sites in 1 country
China5 sites
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570000
Zhenqiang Zhao, +86 13976015677, zhenqiang.zhao@qq.com
hongdaojun@hotmail.com
The First People's Hospital of Jingdezhen City
Jingdezhen, Jiangxi, 341000
Shunfu Jiang, +86 18907982686, shenli869@163.com
The First People's Hospital of Jiujiang City
Jiujiang, Jiangxi, 341000
Tuanyuan Zheng, +86 13507925845, zty13507925845@163.com
The First Affiliated Hospital of Gannan Medical University
Nanchang, Jiangxi, 341000
Qiujiang Xi, +86 18170868978, Xiqiujiang992437@sina.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 341000
Daojun Hong, +86 13879187691, hongdaojun@hotmail.com
hongdaojun@hotmail.com
About this study
Official title: Efficacy and Safety of Tirofiban Combined With Aspirin in Moderate Ischemic Stroke: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Ischemic stroke accounts for the majority of stroke cases in China, and moderate ischemic stroke (NIHSS 4-10) carries a high risk of early neurologic deterioration (END) and long-term disability. Although intensified antiplatelet strategies reduce END, they have not consistently improved long-term functional outcome. Tirofiban, a selective glycoprotein IIb/IIIa receptor inhibitor, has shown a clinically meaningful trend toward better 90-day functional outcome (mRS 0-1) in prior tirofiban trials, but existing sample sizes were underpowered to detect this difference.
TAMIS is a multicenter, randomized, double-blind, placebo-controlled superiority trial in patients with acute moderate ischemic stroke (NIHSS 4-10) within 24 hours of last known well. Eligible patients are randomized 1:1 to tirofiban plus aspirin versus placebo plus aspirin, both on a background of guideline-based standard medical care. The primary efficacy endpoint is the proportion of patients with an excellent functional outcome (mRS 0-1) at 90 days. The primary safety endpoint is symptomatic intracranial hemorrhage within 48 (±12) hours by the Heidelberg criteria.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Tirofiban, Tirofiban-matching placebo
- 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
Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban after randomization: 0.4 µg/kg/min for the first 30 minutes, then 0.1 µg/kg/min for a total of 24 hours. Plus guideline-based standard care.
Tirofiban-matching placeboDrug
Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban-matching placebo infusion (0.4 µg/kg/min × 30 min, then 0.1 µg/kg/min × 24 h). Plus guideline-based standard care.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban + Aspirin | Experimental | Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban after randomization: 0.4 µg/kg/min for the first 30 minutes, then 0.1 µg/kg/min for a total of 24 hours. Plus guideline-based standard care. Receives: Drug: Tirofiban |
| Placebo + Aspirin | Placebo comparator | Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban-matching placebo infusion (0.4 µg/kg/min × 30 min, then 0.1 µg/kg/min × 24 h) after randomization. Plus guideline-based standard care. Receives: Drug: Tirofiban-matching placebo |
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 (%)
Proportion of patients achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0 or 1 at 90 days after randomization.
Measured: At 90 days after randomization
Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)
Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)
Measured: 48 (±12) hours after randomization
Secondary outcomes (9)
mRS score at 90 days (ordinal shift analysis)
mRS score at 90 days (ordinal shift analysis)
Measured: At 90 days after randomization
Proportion with functional independence (mRS 0-2) at 90 days
Proportion with functional independence (mRS 0-2) at 90 days
Measured: At 90 days after randomization
Early neurologic deterioration (END) within 7 ± 1 days
Early neurologic deterioration (END) within 7 ± 1 days, defined as an increase in NIHSS ≥ 2 points within 7 days, with the hemiparesis item increasing ≥ 1 or the level-of-consciousness item increasing ≥ 1, after excluding intracranial hemorrhage or other non-stroke causes.
Measured: Within 7 ± 1 days after randomization
Change in NIHSS from pre-randomization to discharge or discharge-day 6 (±1)
Change in NIHSS from pre-randomization to discharge or discharge-day 6 (±1)
Measured: Discharge or discharge-day 6 (±1)
EQ-5D-5L at 90 days
EQ-5D-5L at 90 days
Measured: At 90 days after randomization
Any intracranial hemorrhage on imaging within 48 (±12) hours
Any intracranial hemorrhage on imaging within 48 (±12) hours
Measured: Within 48 (±12) hours after randomization
90-day all-cause mortality
90-day all-cause mortality
Measured: At 90 days after randomization
Major extracranial bleeding within 48 (±12) hours (GUSTO moderate and severe)
Major extracranial bleeding within 48 (±12) hours (GUSTO moderate and severe)
Measured: Within 48 (±12) hours after randomization
Non-hemorrhagic serious adverse event rate
Non-hemorrhagic serious adverse event rate (including cerebral hernia, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis, psychiatric symptoms, etc.)
Measured: Within 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated 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
- NCT07760922
- Sponsor's protocol ID
- TAMIS
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data without patient information
Publications
Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
PubMed 38648030Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.
PubMed 37256974
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tirofiban Combined With Aspirin in Moderate Ischemic Stroke: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07760922
- Acronym / sponsor ID
- TAMIS
- Conditions
- Ischemic Stroke, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,168 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Aug 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.
Ischemic stroke accounts for the majority of stroke cases in China, and moderate ischemic stroke (NIHSS 4-10) carries a high risk of early neurologic deterioration (END) and long-term disability. Although intensified antiplatelet strategies reduce END, they have not consistently improved long-term functional outcome. Tirofiban, a selective glycoprotein IIb/IIIa receptor inhibitor, has shown a clinically meaningful trend toward better 90-day functional outcome (mRS 0-1) in prior tirofiban trials, but existing sample sizes were underpowered to detect this difference.
TAMIS is a multicenter, randomized, double-blind, placebo-controlled superiority trial in patients with acute moderate ischemic stroke (NIHSS 4-10) within 24 hours of last known well. Eligible patients are randomized 1:1 to tirofiban plus aspirin versus placebo plus aspirin, both on a background of guideline-based standard medical care. The primary efficacy endpoint is the proportion of patients with an excellent functional outcome (mRS 0-1) at 90 days. The primary safety endpoint is symptomatic intracranial hemorrhage within 48 (±12) hours by the Heidelberg criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban + Aspirin | Experimental | Drug: TirofibanAspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban after randomization: 0.4 µg/kg/min for the first 30 minutes, then 0.1 µg/kg/min for a total of 24 hours. Plus guideline-based standard care. |
| Placebo + Aspirin | Placebo comparator | Drug: Tirofiban-matching placeboAspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban-matching placebo infusion (0.4 µg/kg/min × 30 min, then 0.1 µg/kg/min × 24 h) after randomization. Plus guideline-based standard care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years;
- Acute ischemic stroke; time from last known well to randomization ≤ 24 hours;
- Pre-randomization NIHSS score 4-10, with at least one of item 5 (upper limb) or item 6 (lower limb) ≥ 1;
- Pre-stroke modified Rankin Scale (mRS) ≤ 1;
- Written informed consent provided by the patient or a legally authorized representative.
Key exclusion criteria (19 listed)
- Intracranial hemorrhage confirmed by CT or MRI;
- Has received or is planned to receive reperfusion therapy (thrombolysis or endovascular treatment);
- Any definite cardioembolic source: chronic/paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction < 30%;
- Definite indication for anticoagulation (atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism);
- Severe systemic disease (e.g., severe infection, severe hepatic or renal dysfunction);
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 |
|---|---|---|
| TirofibanAspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban after randomization: 0.4 µg/kg/min for the first 30 minutes, then 0.1 µg/kg/min for a total of 24 hours. Plus guideline-based standard care. | Drug | Tirofiban + Aspirin |
| Tirofiban-matching placeboAspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban-matching placebo infusion (0.4 µg/kg/min × 30 min, then 0.1 µg/kg/min × 24 h). Plus guideline-based standard care. | Drug | Placebo + Aspirin |
Primary outcome
Proportion of patients with mRS 0-1 at 90 days (%)
Time frame: At 90 days after randomization
Proportion of patients achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0 or 1 at 90 days after randomization.
Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)
Time frame: 48 (±12) hours after randomization
Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)
9 secondary outcomes
mRS score at 90 days (ordinal shift analysis)
Time frame: At 90 days after randomization
Proportion with functional independence (mRS 0-2) at 90 days
Time frame: At 90 days after randomization
Early neurologic deterioration (END) within 7 ± 1 days
Time frame: Within 7 ± 1 days after randomization
Change in NIHSS from pre-randomization to discharge or discharge-day 6 (±1)
Time frame: Discharge or discharge-day 6 (±1)
EQ-5D-5L at 90 days
Time frame: At 90 days after randomization
Any intracranial hemorrhage on imaging within 48 (±12) hours
Time frame: Within 48 (±12) hours after randomization
90-day all-cause mortality
Time frame: At 90 days after randomization
Major extracranial bleeding within 48 (±12) hours (GUSTO moderate and severe)
Time frame: Within 48 (±12) hours after randomization
Non-hemorrhagic serious adverse event rate
Time frame: Within 90 days 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 12 Aug 2026.
- Background: PubMed 38648030Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
- Background: PubMed 37256974Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.
- Individual participant dataSharing planned: Yes. Study data without patient information
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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.
Jing Lin, MD contact
Zhongming Qiu principal investigator
Xinqiao Hospital of the Army Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirofiban in people with Ischemic Stroke, Acute, run by Xinqiao Hospital of Chongqing at 5 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 5 inclusion and 19 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Daojun Hong, MD (+8613879187691, hongdaojun@hotmail.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: At 90 days after randomization). The study lists 2 primary outcomes in all. 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 NCT07760922, which also lists 2 linked publications.
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 12 Aug 2026.