Mild StrokePhase 4TiMISNCT07095790
Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke
A Phase 4 study testing Tirofiban+Oral Dual Antiplatelet Therapy and Oral Dual Antiplatelet Therapy in people with Mild Stroke, run by Second Affiliated Hospital of Soochow University at 18 sites in China.
Trial summary
This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Stroke
- What is being tested?
- Tirofiban+Oral Dual Antiplatelet Therapy and Oral Dual Antiplatelet Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 18 sitesChina
- Study dates
- 30 Aug 2025to 31 May 2027
- 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 old.
- Acute mild non-cardioembolic stroke.
- NIHSS score ≤5.
- Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours.
- The investigational drug can be administered within 48 hours of symptom onset.
- Signed informed consent by the patient or legally authorized representative.
Who cannot join
- Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
- Intracranial hemorrhage confirmed by imaging.
- Pre-stroke modified Rankin Scale (mRS) score ≥2.
- Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction <30%.
- History of primary intracerebral hemorrhage.
- History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
Show all 17Show fewer
- Untreated or inadequately treated intracranial aneurysm or vascular malformation.
- Major systemic bleeding within 30 days.
- Active bleeding, including laboratory evidence of coagulopathy (platelet count <100 × 10⁹/L, activated partial thromboplastin time >50 seconds, or international normalized ratio >1.7), or treatment with direct oral anticoagulants within the preceding 48 hours.
- Major surgery within 14 days.
- Persistently elevated blood pressure (systolic >180 mmHg or diastolic >110 mmHg) despite treatment.
- Baseline platelet count <100 × 10⁹/L.
- Severe renal dysfunction (glomerular filtration rate <30 mL/min or serum creatinine >220 μmol/L [2.5 mg/dL]).
- Known allergy or contraindication to tirofiban or aspirin.
- Current pregnancy or lactation.
- Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).
- Any terminal illness with life expectancy <6 months.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yongjun Cao, M.D, PhD contact
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
WuYuan County People's Hospital
Bayan Nur, Inner Mongolia
Yongming Chen, cyongm2010@163.com
- Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu
Kun An, ankunsjnk@njmu.edu.cn
- Recruiting
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Zichun Zhao, zhaozichun83@163.com
- Recruiting
Jiangsu Province (Suqian) Hospital
Suqian, Jiangsu
Dan Li, 343129771@qq.com
- Recruiting
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui
Yingzhi Liang
- Recruiting
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
- Recruiting
Affiliated Jiangsu Shengze Hospital of Nanjing Medical University
Suzhou, Jiangsu
Shenglong Wang, 2837012866@qq.com
- Recruiting
Changshu No.1 People's Hospital
Suzhou, Jiangsu
Taosheng Lu, lutaosheng@163.com
- Recruiting
First People's Hospital of Kunshan
Suzhou, Jiangsu
Guihua Miao, mghmty@126.com
- Recruiting
Suzhou Ninth People's Hospital
Suzhou, Jiangsu
Guojie Zhai, 125461985@qq.com
- Recruiting
Suzhou Xiangcheng People's Hospital
Suzhou, Jiangsu
Xiaoyun Han, 15895561709@163.com
- Recruiting
Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou, Jiangsu
15850297009@139.com
- Recruiting
Zhangjiagang Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu
Yaming Sun, sunyaming2001@126.com
- Recruiting
Taixing Second People's Hospital
Taizhou, Jiangsu
Ligong Ji, 420643682@qq.com
- Recruiting
Second Hospital of Tianjin Medical University
Tianjin
Dongliang Wang, wdl.021705@163.com
- Recruiting
Nuclear Industry 417 Hospital
Xi'an, Shaanxi
Tao Xu, xutao_417@126.com
- Recruiting
First People's Hospital of Xianyang
Xianyang, Shaanxi
Yugang Wang, yugangwang@126.com
- Recruiting
Taikang Xian People's Hospital
Zhoukou, Henan
Haiyang Shu, shuhaiyang1989@163.com
About this study
Official title: Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
Read the detailed description
Although dual antiplatelet therapy (DAPT) reduces stroke recurrence and disability risks, its efficacy is limited in patients with mild ischemic stroke (NIHSS ≤5), among whom early neurological deterioration (END) and poor functional outcomes are frequently observed. Notably, intravenous thrombolysis is not more effective than DAPT for mild stroke management. Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, has shown potential efficacy in mild-to-moderate ischemic stroke, but robust evidence specific to mild stroke remains lacking. This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
- Conditions
- Mild Stroke
- Being tested
- Tirofiban+Oral Dual Antiplatelet Therapy, Oral Dual Antiplatelet Therapy
- Keywords
- Tirofiban; Dual Antiplatelet Therapy; Mild Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirofiban+Oral Dual Antiplatelet TherapyDrug
Also called Tirofiban with Sequential Dual Antiplatelet Therapy
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 47.5 hours; sequential Oral Dual Antiplatelet Therapy (Aspirin 100mg qd; Clopidogrel 75mg qd)
Oral Dual Antiplatelet TherapyDrug
Also called Dual Antiplatelet Therapy, Aspirin plus Clopidogrel
Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban+Oral Dual Antiplatelet Therapy | Experimental | Patients will receive tirofiban in the first 48 hours and then be switched to oral dual antiplatelet therapy thereafter Receives: Drug: Tirofiban+Oral Dual Antiplatelet Therapy |
| oral dual antiplatelet therapy | Active comparator | Patients will receive oral dual antiplatelet therapy alone Receives: Drug: Oral Dual Antiplatelet Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of excellent functional outcomes (mRS 0-1)
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death)
Measured: 90 days
Secondary outcomes (10)
Incidence of early neurological deterioration
more than 2 National Institutes of Health Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline. National Institutes of Health Stroke Scale: stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Measured: 72 hours
Incidence of early neurological improvement
National Institutes of Health Stroke Scale score of 0 or improvement ≥2 points from baseline. National Institutes of Health Stroke Scale: stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms
Measured: 72 hours
Change in National Institutes of Health Stroke Scale score from baseline
National Institutes of Health Stroke Scale: stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms
Measured: 7 days
Proportion of good functional outcomes (mRS 0-2)
good functional outcomes (mRS 0-2)
Measured: 90 days
Distribution of mRS scores
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death)
Measured: 90 days
Incidence of schemic stroke
new schemic stroke
Measured: 90 days
Incidence of major adverse cardiovascular events
including ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, and vascular death
Measured: 90 days
Rate of symptomatic intracerebral hemorrhage
Symptomatic intracranial hemorrhage is defined according to the ECASS Classification
Measured: 7 days
Rate of all-cause mortality
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
Measured: 90 days
Rate of major bleeding events
defined by the GUSTO bleeding criteria
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start30 Aug 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (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 Mild 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jijun Shi, M.D, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095790
- Sponsor's protocol ID
- LK2025063
- Other IDs
- 2024yb48
- Acronym
- TiMIS
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Peng H, Zhu Y, Xu F, Zhu L, Yang J, Kang T, Wang S, Yu X, Liu J, Wang P, Zhang M, Liu CF, Cao Y, Shi J. Tirofiban with sequential dual antiplatelet therapy in mild acute ischemic stroke (TiMIS): protocol for a multicenter, randomized controlled trial. Ann Med. 2026 Dec;58(1):2644698. doi: 10.1080/07853890.2026.2644698. Epub 2026 Mar 15.
PubMed 41834238
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07095790
- Acronym / sponsor ID
- TiMIS / LK2025063
- Conditions
- Mild Stroke
- Keywords
- Tirofiban; Dual Antiplatelet Therapy; Mild Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 31 Jul 2025 (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.
This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
Detailed description
Although dual antiplatelet therapy (DAPT) reduces stroke recurrence and disability risks, its efficacy is limited in patients with mild ischemic stroke (NIHSS ≤5), among whom early neurological deterioration (END) and poor functional outcomes are frequently observed. Notably, intravenous thrombolysis is not more effective than DAPT for mild stroke management. Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, has shown potential efficacy in mild-to-moderate ischemic stroke, but robust evidence specific to mild stroke remains lacking. This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban+Oral Dual Antiplatelet Therapy | Experimental | Drug: Tirofiban+Oral Dual Antiplatelet TherapyPatients will receive tirofiban in the first 48 hours and then be switched to oral dual antiplatelet therapy thereafter |
| oral dual antiplatelet therapy | Active comparator | Drug: Oral Dual Antiplatelet TherapyPatients will receive oral dual antiplatelet therapy alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-80 years old.
- Acute mild non-cardioembolic stroke.
- NIHSS score ≤5.
- Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours.
- The investigational drug can be administered within 48 hours of symptom onset.
Key exclusion criteria (17 listed)
- Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
- Intracranial hemorrhage confirmed by imaging.
- Pre-stroke modified Rankin Scale (mRS) score ≥2.
- Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction <30%.
- History of primary intracerebral hemorrhage.
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+Oral Dual Antiplatelet TherapyAlso: Tirofiban with Sequential Dual Antiplatelet TherapyTirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 47.5 hours; sequential Oral Dual Antiplatelet Therapy (Aspirin 100mg qd; Clopidogrel 75mg qd) | Drug | Tirofiban+Oral Dual Antiplatelet Therapy |
| Oral Dual Antiplatelet TherapyAlso: Dual Antiplatelet Therapy, Aspirin plus ClopidogrelAspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg) | Drug | oral dual antiplatelet therapy |
Primary outcome
Proportion of excellent functional outcomes (mRS 0-1)
Time frame: 90 days
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death)
10 secondary outcomes
Incidence of early neurological deterioration
Time frame: 72 hours
Incidence of early neurological improvement
Time frame: 72 hours
Change in National Institutes of Health Stroke Scale score from baseline
Time frame: 7 days
Proportion of good functional outcomes (mRS 0-2)
Time frame: 90 days
Distribution of mRS scores
Time frame: 90 days
Incidence of schemic stroke
Time frame: 90 days
Incidence of major adverse cardiovascular events
Time frame: 90 days
Rate of symptomatic intracerebral hemorrhage
Time frame: 7 days
Rate of all-cause mortality
Time frame: 90 days
Rate of major bleeding events
Time frame: 90 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 31 Jul 2025.
- Derived from this study: PubMed 41834238Xu J, Peng H, Zhu Y, Xu F, Zhu L, Yang J, Kang T, Wang S, Yu X, Liu J, Wang P, Zhang M, Liu CF, Cao Y, Shi J. Tirofiban with sequential dual antiplatelet therapy in mild acute ischemic stroke (TiMIS): protocol for a multicenter, randomized controlled trial. Ann Med. 2026 Dec;58(1):2644698. doi: 10.1080/07853890.2026.2644698. Epub 2026 Mar 15.
- Individual participant dataSharing planned: No
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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.
Yongjun Cao, M.D, PhD contact
Jijun Shi, M.D principal investigator
Second Affiliated Hospital of Soochow University
18 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+Oral Dual Antiplatelet Therapy and Oral Dual Antiplatelet Therapy in people with Mild Stroke, run by Second Affiliated Hospital of Soochow University at 18 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 31 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 18 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 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 Jijun Shi, M.D (+86 512 67783689, shijijun2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of excellent functional outcomes (mRS 0-1) (time frame: 90 days). 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 NCT07095790, 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 31 Jul 2025.