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| ID | Type | Description | Link |
|---|---|---|---|
| 2024yb48 | Other Grant/Funding Number | Scientific research project of Xi'an Health Commission |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| oral dual antiplatelet therapy | Active Comparator | Patients will receive oral dual antiplatelet therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban+Oral Dual Antiplatelet Therapy | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jijun Shi, M.D | Contact | +86 512 67783689 | shijijun2008@126.com | |
| Yongjun Cao, M.D, PhD | Contact | yongjuncao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jijun Shi, M.D | Second Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Municipal Hospital of Anhui Province | Recruiting | Suzhou | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41834238 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2025 | Jul 23, 2025 |
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|
| Oral Dual Antiplatelet Therapy | Drug | Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg) |
|
|
| 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 |
| 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 | 7 days |
| Proportion of good functional outcomes (mRS 0-2) | good functional outcomes (mRS 0-2) | 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) | 90 days |
| Incidence of schemic stroke | new schemic stroke | 90 days |
| Incidence of major adverse cardiovascular events | including ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, and vascular death | 90 days |
| Rate of symptomatic intracerebral hemorrhage | Symptomatic intracranial hemorrhage is defined according to the ECASS Classification | 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). | 90 days |
| Rate of major bleeding events | defined by the GUSTO bleeding criteria | 90 days |
| Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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| Taikang Xian People's Hospital | Recruiting | Zhoukou | Henan | China |
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| WuYuan County People's Hospital | Recruiting | Bayan Nur | Inner Mongolia | China |
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| Huai'an First People's Hospital | Recruiting | Huai'an | Jiangsu | China |
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| Jiangsu Province (Suqian) Hospital | Recruiting | Suqian | Jiangsu | China |
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| Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215004 | China |
| Affiliated Jiangsu Shengze Hospital of Nanjing Medical University | Recruiting | Suzhou | Jiangsu | China |
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| Changshu No.1 People's Hospital | Recruiting | Suzhou | Jiangsu | China |
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| First People's Hospital of Kunshan | Recruiting | Suzhou | Jiangsu | China |
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| Suzhou Ninth People's Hospital | Recruiting | Suzhou | Jiangsu | China |
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| Suzhou Xiangcheng People's Hospital | Recruiting | Suzhou | Jiangsu | China |
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| Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine | Recruiting | Suzhou | Jiangsu | China |
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| Zhangjiagang Hospital of Traditional Chinese Medicine | Recruiting | Suzhou | Jiangsu | China |
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| Taixing Second People's Hospital | Recruiting | Taizhou | Jiangsu | China |
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| Nuclear Industry 417 Hospital | Recruiting | Xi'an | Shaanxi | China |
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| First People's Hospital of Xianyang | Recruiting | Xianyang | Shaanxi | China |
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| Second Hospital of Tianjin Medical University | Recruiting | Tianjin | China |
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| SAP_000.pdf |
| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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